N/A
Completed N=120
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
Source: ClinicalTrials.gov NCT03112473 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Fugl Meyer Assessment on Upper Extremity (FMA-UE) — 37.03; 41.83; 38.77; 43.93 score on a scale
Summary
On the basis that the combined use of Uni-TENS and TRT is an effective intervention in upper limb recovery, and the advantage of Bi-TENS eliciting extra neural pathway in the intact hemisphere to facilitate the motor recovery, There is a research gap in whether the Bi-TENS over both the paretic and non-paretic limbs could probably augment the treatment effects of TOT in upper limb motor control in people with stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl Meyer Assessment on Upper Extremity (FMA-UE) |
37.03; 41.83; 38.77; 43.93; 41.27; 43.60 | — |
| SECONDARY Jacket Test (JT) |
36.51; 36.98; 36.87; 33.36; 33.02; 35.78 | — |
| SECONDARY Maximal Voluntary Contraction (MVC)-Peak Torque |
3.69; 4.51; 4.86; 5.13; 4.40; 4.77 | — |
| SECONDARY Action Research Arm Test (ARAT) |
28.70; 31.73; 28.30; 34.97; 31.27; 33.93 | — |
| SECONDARY The Range of Motion (ROM) of Upper Limb Joints |
76.67; 85.73; 82.88; 90.22; 84.70; 84.33 | — |
| SECONDARY Motor Activity Log (MAL) |
34.03; 49.72; 39.20; 45.28; 35.57; 44.93 | — |
| SECONDARY Chinese Version of Community Integration Measure (CIM) |
39.47; 41.23; 41.87; 39.67; 41.23; 39.90 | — |
| SECONDARY Maximal Voluntary Contraction (MVC)-Cocontraction Ratio |
0.28; 0.24; 0.25; 0.24; 0.26; 0.27 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will be recruited from local self-help groups through poster advertising.
- Subjects will be included if they are between 50 and 80 years of age
- Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
- have volitional control of the non-paretic arm and at least minimal antigravity movement in the shoulder of the paretic arm,
- have at least 5º in wrist extension in the antigravity position,
- score > 6 out of 10 in the Abbreviated Mental Test, and
- are able to follow instructions and give informed consent.
Exclusion Criteria
- • have any additional medical, cardiovascular or orthopedic condition
- use a cardiac pacemaker
- have receptive dysphasia
- have a significant upper limb peripheral neuropathy
- are involved in drug studies or other clinical trials, or
- have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm, and
- have a skin allergy that would prevent electrical stimulation.
Data sourced from ClinicalTrials.gov (NCT03112473). 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. Informational only — not medical advice.