N/A
N=20
A Telerehabilitation Program for SCI
Incomplete Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT04977037 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) — 64.9; 58.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active tDCS (Device); Sham tDCS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) |
72.1; 57.7 | — |
| PRIMARY Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) |
72.1; 57.7 | — |
| PRIMARY Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) |
72.1; 57.7 | — |
| SECONDARY Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended |
9.6; 9.0 | — |
| SECONDARY Adherence With the Therapy as Assessed by the Number of Participant Drop-outs |
2; 1 | — |
| SECONDARY Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS) |
9.1; 9.1 | — |
| SECONDARY Grip Strength |
24.6; 11.3 | — |
| SECONDARY Grip Strength |
24.6; 11.3 | — |
| SECONDARY Grip Strength |
24.6; 11.3 | — |
| SECONDARY Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) |
11.6; 7.5 | — |
| SECONDARY Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) |
11.6; 7.5 | — |
| SECONDARY Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) |
11.6; 7.5 | — |
| SECONDARY Number of Participants Who Had Adverse Events |
1; 2 | — |
| SECONDARY Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS) |
1.1; 1 | — |
| SECONDARY 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) |
1.1; 1.7 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04977037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.