A Telerehabilitation Program for SCI

Incomplete Spinal Cord Injury Clinical Trial

Official title:

Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977037
• Other study ID #: HSC-MS-21-0114
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Nuray Yozbatiran, PhD, PT
• Phone: 7137975282
• Email: Nuray.Yozbatiran[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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;

2. upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;

3. no brain injury;

4. no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;

5. no contradiction to tDCS;

6. access to internet at home.

Exclusion Criteria:

1. prior history of seizure;

2. chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants);

3. any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score = than 3 out of 4.

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

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 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.

Locations

Country	Name	City	State
United States	The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Mission Connect a project of TIRR Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	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	Change from baseline at 2 weeks and at 1 month
Secondary	Adherence with the therapy	Number of sessions attended	Treatment Day 1- Day 10
Secondary	Adherence with the therapy	Number of drop-outs	Between enrollment and 1-month follow-up
Secondary	Feasibility of home intervention	Participants perception in usefulness of intervention on a scale from 0-10. Higher numbers reflecting higher usability.	Change from baseline at 2 weeks and at 1 month
Secondary	Grip Strength	Maximum force generated by hand muscles and measured with a hand-held dynamometer	Change from baseline at 2 weeks and at 1 month
Secondary	Spinal Cord Injury Independence Measure (SCIM III)-Self Care	Assessment of achievements of self care, score ranges between 0 to 20 with higher numbers reflecting higher level of independence in daily functions	Change from baseline at 2 weeks and at 1 month
Secondary	Incidence of adverse events	Collection of adverse events during the treatment period.	From treatment day1 to treatment day10