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Acta Biomed 2023; Vol. 94, N. 5 e2023255
DOI: 10.23750/abm.v94i5.14408
©Mattioli 1885
Health professions
Using “functional hand” protocol to improve hand function
following a spinal cord injury: An explorative study
Gianluca Ciardi1,2, Gianfranco Lamberti1,2, Martina Avanzi3
1
Department of Rehabilitative Medicine, Azienda USL Piacenza; 2Degree course of Physiotherapy, University of Parma;
Degree course of Physiotherapy student, University of Parma
3
Abstract. Background and aim of the work: A cervical spinal cord injury often affects hand control, causing
ineffective grasping and handling functions, with a negative impact on patient’s independence and quality of
life. Literature recognises scientific evidence only for surgical or instrumental re-education approaches. The
purpose of this study is to present the “functional hand” protocol, a physiotherapy tool that, to date, represents
a good clinical practice but has no supporting literature. Research design and methods: a longitudinal-single
cohort study was conducted at Spinal Unit- Azienda Usl Piacenza. Patients with spinal cord injury at C
5-C7
neurologic level, older than 18 years, with correct comprehension of Italian language were recruited. All
patients were evaluated with Action Research Arm Test (ARAT) scale to state hand functionality; positive/
negative history of Functional Hand protocol was deducted by physiotherapy discharge letters on first spinal
unit hospitalisation. Results: six patients were involved in the study; three of them had a positive history of
protocol application. ARAT scores differences showed that patients who underwent functional hand protocol
had a lower impairment, a better ability to produce cylindrical and cuboid sockets. Conclusions: Functional
hand protocol reached a preliminary evidence as effective tool to improve hand recovery in tetraplegic patients; future studies should confirm these conclusions on larger samples, and verify protocol effectiveness in
addition to other treatment strategies (functional electric stimulation/ transcranial direct current stimulation/
robotic assisted therapy). (www.actabiomedica.it)
Key words: tetraplegia, functional hand protocol, ARAT, inpatient rehabilitation
Introduction
Spinal cord injuries (SCI) affect over 2.5 million
people in the world, causing tetraplegia and paraplegia; they’re often result of car accidents, falls, gunshot
wound, sport injuries (1-2); SCI represents a lifelong
condition, with a devastating impact on quality of
life, self-efficacy and social participation (3-8). More
than half of SCI occurs at cervical level, determining a
motor outcome of tetraplegia and impairment of upper
limb/hand function (9-10). The loss of hand function
is a devastating element in the daily life of a tetraplegic patient, as it entails a high degree of dependence by external caregivers for both simple activities
(BADL-basic activities of daily life) and instrumental
activities (IADL-instrumental activities of daily life)
(11-12).
Physical therapists, so, devote ample space to
rehabilitation approaches dedicated to upper limb
recovery, often combining exercise treatment with occupational therapy. Nevertheless, to date, less is known
about evidence of these rehabilitation approaches on
final hand function, due to a general lack of studies
about.
A previous systematic review by our group (13)
demonstrated that, by existing evidence, four main
interventions are known in literature (alone or combined): robotic hand workstation, functional electric
2
stimulation (FES), transcranial direct current stimulation (TDCS), acute intermittent hypoxia (14-21);
examining non-instrumental approaches, however, no
clear evidence emerged.
A good clinical practice in Italy, to date, is represented by the “Functional Hand” approach, created
and implemented by CNOPUS (Consesso Nazionale
Operatori Unità Spinale) in 2000 (22): the protocol,
specifically developed for tetraplegic patients, represents a standard in many spinal centres to improve
hand function. Its peculiarity is the development of
a structured shortening of fingers and thumb’s flexor
muscles, so to make the patient able to perform light,
functional and useful everyday grips; functional hand
needs to be supported by the activity of radial extensor
of carpus, or by an orthosis to stabilize the wrist (thus
permits movement through biceps activation). SCI
patients with a lesion level between C5 and C7 are assessed for functional hand, which can be offered in the
passive form (without activation of the radial extensor
of the carpus- neurologic level C5) or in the active one
(with activation of the carpus-neurological level C6);
patients with a C7 level are only considered suitable if
an imbalance of strength between finger extensors vs
flexors muscles occurs.
In its passive form (neurologic C5 level), the
functional hand is packaged through a brace that
stabilises the wrist at 30 degrees of extension, while
metacarpophalangeal and proximal interphalangeal
joints are held in 90-degree flexion through patches;
distal interphalangeal joints are held in extension. For
active (neurologic C6 level) form, the patch is placed
longitudinally on the fingers to hold the flexion of the
metacarpophalangeal and proximal interphalangeal
joints. The functional hand is held for several hours a
day (up to 23 hours), freeing it for hygiene and mobilisation, and in the first days a strategy for monitoring
the hand, the appearance of redness or allergic skin reactions is structured.
Despite the extensive clinical use of Functional
Hand protocol, to date, there is no supporting literature validating its efficacy; the aim of the present study
is to provide, by means of a longitudinal investigation,
the long-term functional outcome in patients who
have experienced functional hand protocol following SCI. The secondary aim of this study is to make a
Acta Biomed 2023; Vol. 94, N. 5 e2023255
comparison treated vs not treated patients, in order to
verify if functional hand protocol was more effective
than usual exercise.
Patients and methods
A longitudinal- single cohort study has been conducted at Fiorenzuola d’Arda Spinal Unit- Azienda
USL Piacenza; the study was approved by Aven
Ethics Committee with protocol n. 2022/0108225
-07/03/2022. Azienda Usl Piacenza gave final approval on 04/04/2022.
The target population for inclusion in our study
was represented by patients with C5-C7 complete
tetraplegia, in whom the involvement of hand function
induced a specific treatment for grip and manipulation
functions.
Incomplete lesions (AIS B at Spinal Unit admission, only sensitivity below neurological level) were
also included. To this goal, a convenience sampling
was carried out from the historical dataset of patients
treated at the Spinal Unit of Villanova sull’Arda (now
Fiorenzuola d’Arda) over the last thirty years, as to include patients admitted before 2000 (the year in which
the functional hand protocol was introduced) as well
as after that date.
Specific inclusion criteria were as follows: more
than 18 years old; complete/incomplete SCI diagnosis according to ISCOS criteria (23) by more
than a year; neurologic level between C5 and C7
(cut-off neurological levels to evaluate the introduction of Functional hand protocol); Italian language
comprehension.
Exclusion criteria were: neurologic level lower
than C8 (innervated hand); tendon transposition surgery; orthopaedic hand disease; psychiatric disorders;
severe spasticity (Ashworth scale score more than 3);
neurodegenerative disorders; muscular retraction. All
exclusion criteria were drawn in order to eliminating
all conditions that could affect hand functions in addition to the primary diagnosis (spinal cord injury).
By the initial historical dataset patients’ name, diagnosis and contact were retrieved; they were so contacted by phone, then a follow up visit was scheduled;
after the visit, participation to the study was proposed.
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Acta Biomed 2023; Vol. 94, N. 5 e2023255
If the patient gave his written consent, a researcher
started the following operations:
- Retrieval of information with respect to the execution of “functional hand” protocol from the
patient’s physiotherapy discharge letters related
to the first post-injury hospitalisation
- Filling case report form (CRF) with patient’s
general data
- Patients evaluation by Action Research Arm
Test (ARAT) scale (24)
Initially introduced by Lyle et al (24) the ARAT
scale was developed to assess arm function for neurologic patients; the scale was historically applied
to stroke patients, but in 2012 was involved among
SCI-Edge tools (25); previous existing RCTS about
arm function in quadriplegia used ARAT as main
outcome (14-15-19). ARAT scale is composed by
19 tests and four sub-scales: Grasp, Grip, Pinch,
Gross-movements (final score 0-56 points); in the
present study pinch sub-scale results were not considered for analysis, as the principle of muscular
shortening of functional hand does not allow a fine
grip (as required by ARAT testing). The test was
conducted on the limb where functional hand was
applied, if both limbs had been treated the worst
performance was recorded. For untreated patients,
both limbs were analysed and the worst performance was recorded. ARAT test kit was purchased
by Amsterdam University Medical Centers (UMC);
no permission was needed to use the tool.
For each patient following general data were
acquired: sex, age, neurologic level and AIS grading,
years by the injury, work, sport (if applicable).
ARAT performing was conducted with a standard positioning: the patient was seated comfortably
on his/her wheelchair, ensuring the correct biomechanical alignment of the lower limbs (hip and knee
positioned at 90° of flexion, ankles in neutral position and in support of the ground or the wheelchair
footplates). If supports for stabilising the trunk were
present, they were allowed. ARAT testing kit was
placed in front of the patient on a table adjusted to
the height of the wheelchair. The following tests were
performed:
- Grasp sub-area: the patient had to carry a
block 10 cm from the horizontal plane to the
top of the kit box; if this task succeeded immediately, the grip test was performed, otherwise
intermediate tests were carried out with cubes
of increasing diameter (2.5 cm, 5 cm, 7.5 cm,
sphere, rectangular stone)
- Grip sub-area: the patient had to pour water
from one glass to another; if the test was successful immediately, the gross movement section was carried out, otherwise intermediate
tests were performed (insert a 2.25 cm cylindrical tube in one chamber, then 1 cm, then insert
a washer over a bolt)
- Gross motor sub-area: the patient had to perform three movements, bring the hand behind
the head, then above the head, then to the
mouth.
Each task was performed for a maximum of
3 trials, with the best attempt being recorded; the score
awarded was 3 if the patient performed the movement
correctly (maximum subarea score if he could perform the first task on the first attempt), 2 if the task
was completed with difficulty or in a longer time of
60 seconds, 1 if the task was only partially performed
in the allotted 60 seconds, 0 if the patient failed to
perform the task.
All data were organized by excel worksheet, and
then re-elaborated in graphic form: mean and individual differences for ARAT total scores and subscales
were considered as primary outcome.
Results
In Figure 1 the study flowchart has been presented: by 15 patients contacted for follow up visit
9 refused to participate, while the other six were assessed for eligibility to the study. They were all eligible
and recruited.
Demographic data of the sample
In Table 1 all collected general data were resumed;
our sample was composed by 5 men (84% of the
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Acta Biomed 2023; Vol. 94, N. 5 e2023255
sample) and 1 woman (16%); mean age at study time
was 54 years old, with a standard deviation of 17.5
years. All patients had a traumatic SCI, with neurological level comprised between C5 and C7. Four patients
had a complete SCI (AIS grading A) while two had
incomplete injury (AIS grading B). One only patient,
at study time, worked as employee, while only another
one practiced sport (wheelchair tennis). By discharge
letter three patients (pt. 1-level C5, pt. 4-level C5, pt.
6-level C5) have been treated with functional hand
protocol during the first hospitalisation.
ARAT scores
The overall analysis of total ARAT score
emonstrated a general trend of higher performances
d
of treated patients; the mean total ARAT score was
of 37/39 points for patient with a positive history of
Functional hand protocol, while not treated patient
had a mean total score of 25.6. See Table 2 for further
details.
The same difference was observed for sub-scales
scores: grasp mean was 17/18 points for treated patient, 10 for not treated patient, so underlying a better
ability to perform a cuboid grasp to manipulate different size blocks. Grip sub scores showed a mean of
11/12 points for treated patients, and of 6 points for
not-treated ones; this value reflects a better ability to
manipulate cylindrical objects. Finally, gross movement sub scores mean was 9/9 for treated patients
and 7/9 for not treated ones, thus indicating a lower
difference. Tasks in this area, however, depend also by
shoulder activation. Figures 2, 3 and 4 reflect single
patient’s results.
Conclusions
Figure 1. Flowchart of study inclusion and eligibility. Alt text:
a four-step flow diagram showing the patient inclusion process:
from an initial number of 15 screened patients, six ones took
part at the study.
The present study was conducted in conformity to
Strobe statement (26). To date, this is the first attempt
to describe a wide used rehabilitative approach to
tetraplegic hand dysfunction. By present single cohort
Table 1. General data of the sample. Pt: patient; SCI: spinal cord injury.
Age (range)
Diagnosis
Neurologic level
AIS Grading
Work
Sport
Years by injury
PT 1
80-90 years
Traumatic SCI
C5-C6
B
NO
NO
13
PT 2
50-60 years
Traumatic SCI
C6
A
NO
NO
35
PT 3
30-40 years
Traumatic SCI
C5
A
NO
NO
22
PT 4
50-60 years
Traumatic SCI
C5
B
YES
NO
2
PT 5
50-60 years
Traumatic SCI
C6-C7
A
NO
YES
29
PT 6
40-50 years
Traumatic SCI
C5
A
NO
NO
1
5
Acta Biomed 2023; Vol. 94, N. 5 e2023255
Table 2. Results of ARAT testing. Pt: patient; RS: right side. All not treated patients were evaluated on both sides, but the worst
performance (right) was analysed; all treated patients had one only side to test, except for PT 6 (both side treated), who had the same
scoring for both arms. In this case right side was involved for data analysis.
FUCNTIONAL HAND
GRASP SCORE
GRIP SCORE
GROSS MOVEMENT
SCORE
TOTAL
PT 1
YES (RS)
16/18
10/12
9/9
35/39
PT 2
NO (RS ANALYSED)
0/18
0/12
3/9
3/39
PT 3
NO (RS ANALYSED)
18/18
6/12
9/9
33/39
PT 4
YES (RS)
16/18
11/12
9/9
36/39
PT 5
NO (RS ANALYSED)
12/18
12/12
9/9
33/39
PT 6
YES (BOTH SIDES- RS
ANALYSED)
18/18
12/12
9/9
39/39
Figure 2. Comparison of Grasp subscale scores between treated/not treated patients. A histogram with individual patients on abscissas and ARAT –Grasp scores on ordinates. Patients treated with functional hand
protocol achieve a higher score.
study results, Functional hand protocol seems to be
an effective tool to restore and preserve hand function even after many years by SCI occurrence: ARAT
scores, in fact, demonstrated a general trend of better
performance in treated patients, even in total scores
than in subscales’ ones. In general terms this indicates
that the procedure is effective to restore hand ability in
confront to exercise only; this could be a first step to
overcome the gap in scientific literature about conservative treatment of tetraplegic hand. A recent literature
review, in fact, shows that, commonly, physiotherapists
have not a clear concept about pathophysiology and
treatment strategies for tetraplegic hand, deriving their
approaches by stroke patients (27). So, due to this evidence lack, research mainly dedicates to surgical approaches: to date, the use of tendon transposition is the
most validated proposal for stable (more than a year by
SCI) tetraplegic patients (28-31). Very little is known
about conservative treatments: even in published experiences (32-35) manual intervention is mainly
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Figure 3. Comparison of Grip subscale scores between treated/not treated patients. A histogram with individual patients on abscissas and ARAT –Grip scores on ordinates. Patients treated with functional hand
protocol achieve a higher score.
ARAT grposs movement scores
GROSS MOVEMENT SCORES
20
15
10
5
0
Pt 1
Pt 4
Pt 6
Pt 2
Pt 3
Pt 5
Figure 4. Comparison of Gross movement scores between treated/not treated patients.
A histogram with individual patients on abscissas and ARAT – Gross movement scores on
ordinates. Patients achieve similar scores, except for patient 2 (not treated with functional
hand protocol) who had a lower score.
used as shame/additional modality, with a low success rate (35). Proposed exercises, moreover, are often
oriented towards repetitiveness and time-exposition;
physiology of a SCI-inducted damage, instead, leads
to confronting with clinical pictures in which motor
outcome is not only the result of neuroplasticity, but
also of root functionality and strength of supra lesional
musculature.
The first novelty we introduce with the present
study is considering tetraplegic hand management
a multidisciplinary task, which requires a close collaboration between doctors, physiotherapists, occupational therapists, nurses and patients. This pathway
starts with a rigorous multimodal evaluation, in which
general medical conditions, motor abilities and selfefficacy are taken into account. In this perspective
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Acta Biomed 2023; Vol. 94, N. 5 e2023255
MRC (medical research council) scale plays a central
role to assess upper limb muscle strength, in order to
verify if functional hand could be active or passive.
Moreover, skin observation helps to identify frailty
due to vascular/dermatological comorbidity, that could
contraindicate protocol application. Once the hand is
closed, the patient accepts this condition for the most
part of the day and within several months, with high
implications for daily life (reduced autonomy, pain).
Determination and devotion are so needed to employ
this tool in an intensive rehabilitation path; our clinical
observation indicates that, on the medium long period,
functional hand restore grasping and handling skills essential for performing many ADLs (feeding, personal
hygiene, self-propulsion in a wheelchair, trunk management during bed-chair transfers and vice versa).
Despite this some criticalities emerged. At first,
our sample is very small, so we can only hypothesise
preliminary evidence of the protocol, which should
further be investigated on larger populations. In addition, ARAT scale seems not completely suitable to explore functional hand principle, since pinch subscale is
not applicable: the protocol is not intended to produce
an interdigital fine-grip capability, but only coarse
cylindrical or handheld typing sockets. Our study, in
conclusion, represents a first step to produce evidence
of functional hand efficacy; future research would better verify this hypothesis on larger samples, and further
test it in intensive rehabilitation setting and with different combination of treatments (i.e. functional hand
+ FES/TDCS/Robotic workstation).
Ethic Committee: The study was approved by Aven Ethics
Committee with protocol n. 2022/0108225 -07/03/2022. Azienda
Usl Piacenza gave final approval on 04/04/2022.
Conflict of Interest: Each author declares that he or she has no
commercial associations (e.g. consultancies, stock ownership, equity
interest, patent/licensing arrangement etc.) that might pose a conflict of interest in connection with the submitted article.
Authors Contribution: Conceptualization, GC and GL; methodology, GC; investigation, GL, MA and GC; writing—original
draft preparation, GC; writing—review and editing, GL and MA.
All authors have read and agreed to the published version of the
manuscript.
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more effective than usual care plus one-to-one hand therapy
in people with sub-acute spinal cord injury (‘Hands On’):
a randomised trial. J Physiother. 2017 Oct;63(4):197-204.
doi: 10.1016/j.jphys.2017.08.005.
Correspondence:
Received: 6 June 2023
Accepted: 22 September 2023
Gianluca Ciardi, PT PH.D
Spinal unit- Azienda Usl Piacenza
Via Roma n.33, Fiorenzuola d’Arda, 29017 Italy
E-mail: gianluca.ciardi@unipr.it