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

Not Applicable

Completed

• Conditions: Spinal Cord Injury at C5-C7 Level
• Interventions: Other: FES+CBA; Other: FES

• Registration Number: NCT04566809
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-21
• Status Verified: 2020-09
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-22
• Last Update Submitted: 2020-09-22
• Study First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental group: FES+CBA	FES+CBA	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.
Control Group: FES	FES	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.

Primary Outcome Measures

Name	Time	Method
Performance test: Bimanual Ability Test (BAT)	2 years	10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills

Secondary Outcome Measures

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