A Telerehabilitation Program for SCI
Study Details
Study Description
Brief Summary
This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Spinal Cord Injury (SCI) has been associated with serious reduction in functional independence. Despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of SCI population are able to receive intensive in-clinic treatment. Difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. Currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. The literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore that CST activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (M1). However, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. To address these questions, 36 adults (above 18 years) with cervical SCI will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. The anodal tDCS will be applied over primary motor cortex (M1) at an intensity of 2mA for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. Primary outcome measure is change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) from baseline to immediately after treatment and 4-weeks follow-up. The session will be supervised in real-time via videoconferencing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active tDCS Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes |
Device: Active tDCS
Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
| Sham Comparator: Sham tDCS Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes |
Device: Sham tDCS
Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Outcome Measures
Primary Outcome Measures
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [Change from baseline at 2 weeks and at 1 month]
This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population
Secondary Outcome Measures
- Adherence with the therapy [Treatment Day 1- Day 10]
Number of sessions attended
- Adherence with the therapy [Between enrollment and 1-month follow-up]
Number of drop-outs
- Feasibility of home intervention [Change from baseline at 2 weeks and at 1 month]
Participants perception in usefulness of intervention on a scale from 0-10. Higher numbers reflecting higher usability.
- Grip Strength [Change from baseline at 2 weeks and at 1 month]
Maximum force generated by hand muscles and measured with a hand-held dynamometer
- Spinal Cord Injury Independence Measure (SCIM III)-Self Care [Change from baseline at 2 weeks and at 1 month]
Assessment of achievements of self care, score ranges between 0 to 20 with higher numbers reflecting higher level of independence in daily functions
- Incidence of adverse events [From treatment day1 to treatment day10]
Collection of adverse events during the treatment period.
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of a chronic incomplete cervical lesion as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months post-injury;
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upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;
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no brain injury;
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no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
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no contradiction to tDCS;
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access to internet at home.
Exclusion Criteria:
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prior history of seizure;
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chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants);
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any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score ≥ than 3 out of 4.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- Mission Connect a project of TIRR Foundation
Investigators
- Principal Investigator: Nuray Yozbatiran, PhD, PT, The University of Texas Health Sciences Center at Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-21-0114