Cognitive Rehabilitation and FES for Hand Functionality in Persons With Cervical Spinal Cord Injury
Cognitive Approach Using Functional Electric Stimulation for Grasp and Pinch Rehabilitation in Persons Affected by Cervical Spinal Cord Injury, a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group: 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.
|
The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy
Other Names:
|
|
Active Comparator: Control Group: 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.
|
The control treatment was formerly composed by 20 sessions of FES for the hand
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance test: Bimanual Ability Test (BAT)
Time Frame: 2 years
|
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)
Time Frame: 2 years
|
The score varies from 0 to 100.
Higher the score, patient more independent in its daily life
|
2 years
|
|
Grasping Strength (GS)
Time Frame: 2 years
|
Grasping Strength evaluated with a dynamometer (from 1 to 90 kg) more kg means more strength
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3879A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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