Cognitive Rehabilitation and FES for Hand Functionality in Persons With Cervical Spinal Cord Injury

Study Overview
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Brief Summary
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16 persons affected by Cervical-SCI were recruited for the study and randomly assigned to the Control Group (CG) or to the Experimental Group (EG). Persons of the CG (n = 8) executed 20 sessions of FES for the rehabilitation of hand functions (grasp or pinch), participants of the EG (n = 8) performed 20 sessions of FES and CBA in addition. The primary assessment was a modified version of Bimanual Activity Test (10 tasks); also, SCIM-II and measurement of grasping strength only in participants submitted to grasp rehabilitation were evaluated.

Detailed Description
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Each participant followed twenty sessions of hand rehabilitation, three times per week. Each treatment, for both CG and EG, lasted about forty minutes. The FES devices chosen for this research stimulated grasp or pinch function: the NESS H200 (NESS Ltd., Ra'anana, Israel) was used if patient needed to improve the grasp functions, otherwise the Microstim (Microstim, Medel, Hamburg, Germany) was used to increase pinch functions. In order to provide FES, the five electrodes of NESS H200 were first humidified with warm water and then inserted in the right size place of the rigid splint worn by the patient, while Microstim was used with four standard electrodes, two for each muscle treated. In both case the stimulation was triggered by the therapist clicking a button (Table 1). The participants of CG received only FES to improve their manipulating skills without the interaction with objects, but only with the muscle contraction induced by the devices. The participants of EG executed FES and CBA treatment which means that during the stimulation they manipulated different tools. In particular, for the first ten sessions the participants were invited to manipulate specific objects: squares, rectangles and pyramids of different sizes; touch on plastic test tubes coated with materials of different consistency; these two exercises were performed both with open and closed eyes. Finally, for the last ten sessions the participants were asked to execute specific tasks, depending on person's life before the lesion.

Official Title
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Cognitive Approach Using Functional Electric Stimulation for Grasp and Pinch Rehabilitation in Persons Affected by Cervical Spinal Cord Injury, a Randomized Controlled Trial

Conditions
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Spinal Cord Injury at C5-C7 Level

Intervention / Treatment
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* Other: FES+CBA
* Other: FES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: C-SCI with neurological level between C2-T1; reduced ability of hand functions; excitable muscles and FES tolerability. Exclusion Criteria: any trauma or surgery to the target hand or upper limb within the last 12 months, amputation of any digits on the target hand, severe spasticity in the target hand or upper limb preventing use of the instruments, experienced autonomic dysreflexia or hypotension in response to FES, any contraindication to FES such as: cardiac pacemaker, epilepsy, forearm fracture, pregnancy, skin lesions, cancer or tumor, intracranial metal implants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group: FES+CBA<br>FES+CBA participants executed FES and CBA treatment which means that during the stimulation they manipulated different tools. In particular, for the first ten sessions the participants were invited to manipulate specific objects: squares, rectangles and pyramids of different sizes; touch on plastic test tubes coated with materials of different consistency; these two exercises were performed both with open and closed eyes. Finally, for the last ten sessions the participants were asked to execute specific tasks, depending on person's life before the lesion. | Other: FES+CBA<br>* The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy<br>* Other names: Functional Electric Stimulation, Cognitive Therapy;|
| Active Comparator: Control Group: FES<br>FES participants received only FES to improve their manipulating skills without the interaction with objects, but only with the muscle contraction induced by the devices. | Other: FES<br>* The control treatment was formerly composed by 20 sessions of FES for the hand<br>* Other names: Functional Electric Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance test: Bimanual Ability Test (BAT) | 10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Cord Independence Measure (SCIM) | The score varies from 0 to 100. Higher the score, patient more independent in its daily life | 2 years | 
| Grasping Strength (GS) | Grasping Strength evaluated with a dynamometer (from 1 to 90 kg) more kg means more strength | 2 years |