A Telerehabilitation Program for SCI

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

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).

Study Overview

• Status: Completed
• Conditions: Incomplete Spinal Cord Injury
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.	Baseline
Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.	2 weeks
Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended		Treatment Day 1- Day 10
Adherence With the Therapy as Assessed by the Number of Participant Drop-outs		Between enrollment and 6 weeks
Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS)	Participants rated the usefulness of the interventions on a scale of 0 to 10, with 0 indicating not useful at all and 10 indicating very useful.	Day 10
Grip Strength	Maximum force generated by hand muscles and measured with a hand-held dynamometer	Baseline
Grip Strength	Maximum force generated by hand muscles and measured with a hand-held dynamometer	2 weeks
Grip Strength	Maximum force generated by hand muscles and measured with a hand-held dynamometer	6 weeks
Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)	Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions.	Baseline
Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)	Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions.	2 weeks
Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)	Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions.	6 weeks
Number of Participants Who Had Adverse Events		from baseline to 6 weeks
Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS)	Participants rated the level of difficulty of using tDCS on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult	Day 10
Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using Exercise Equipment as Assessed by the Visual Analog Scale (VAS)	Participants rated the level of difficulty of using exercise equipment on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult.	Day 10

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Mission Connect a project of TIRR Foundation
• Investigators: Principal Investigator: Nuray Yozbatiran, PhD, PT, The University of Texas Health Sciences Center at Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: tDCS; upper limb; Cervical Spinal Cord Injury; telerehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: HSC-MS-21-0114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes