Skip to main content
OpenTrials
Completed

NCT Number: NCT04977037

A Telerehabilitation Program for SCI

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;
  • no brain injury;
  • no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  • no contradiction to tDCS;
  • access to internet at home.

Exclusion criteria

  • prior history of seizure;
  • chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants);
  • any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score ≥ than 3 out of 4.

Treatment and study plan

active tDCS

Device

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

Device

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.

Primary outcomes

  1. Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

    Time frame: Baseline

    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. Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

    Time frame: 2 weeks

    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.

  3. Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended

    Time frame: Treatment Day 1- Day 10

  2. Adherence With the Therapy as Assessed by the Number of Participant Drop-outs

    Time frame: Between enrollment and 6 weeks

  3. Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS)

    Time frame: Day 10

    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.

  4. Grip Strength

    Time frame: Baseline

    Maximum force generated by hand muscles and measured with a hand-held dynamometer

  5. Grip Strength

    Time frame: 2 weeks

    Maximum force generated by hand muscles and measured with a hand-held dynamometer

  6. Grip Strength

    Time frame: 6 weeks

    Maximum force generated by hand muscles and measured with a hand-held dynamometer

  7. Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)

    Time frame: Baseline

    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.

  8. Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)

    Time frame: 2 weeks

    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.

  9. Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)

    Time frame: 6 weeks

    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.

  10. Number of Participants Who Had Adverse Events

    Time frame: from baseline to 6 weeks

  11. Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS)

    Time frame: Day 10

    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

  12. 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)

    Time frame: Day 10

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Mission Connect a project of TIRR Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2021
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.