N/A
Completed N=31
Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection
Hemiplegia, Spastic · Spastic
Source: ClinicalTrials.gov NCT04826900 ↗
Enrolled (actual)
31
Serious AEs
—
Results posted
Jun 2023
Primary outcomePrimary: Fugl-Meyer Assessment (FMA) — 3; 6 score on a scale
Summary
The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with wearable robotic hand system (RT) and Robotic mirror therapy (RMT) in patients with spastic hemiplegic stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment (FMA) |
3; 6 | — |
| PRIMARY Medical Research Council Scale (MRC) |
0.30; 0.35; 0.17; 0.17; 0.25; 0.50 | — |
| PRIMARY Modified Ashworth Scale (MAS) |
-0.33; -0.17; -0.42; -0.17; -0.25; 0.00 | — |
| PRIMARY Box and Block Test (BBT) |
0; 0 | — |
| PRIMARY Motor Activity Log (MAL) - Amount of Use Scale (AOU) |
0.14; 0.34 | — |
| PRIMARY Motor Activity Log (MAL) - Quality of Movement Scale (QOM) |
0.15; 0.21 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- Finger flexor muscles spasticity (modified Ashworth scale of ≥ 1+)
- Initial motor part of UE of FMA score ranging from 10 to 56 indicating moderate to severe movement impairment
- No serious cognitive impairment (i.e., Mini Mental State Exam score > 20)
- Age ≥ 20 years
Exclusion Criteria
- Pregnant
- With bilateral hemispheric or cerebellar lesions
- Sever aphasia
- Significant visual field deficits or hemineglect
- Contraindication for BoNT-A injection
- Treatment with BoNT-A within 6 months before recruitment
- Any fixed joint contracture of the affected upper limb
- A history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol
Data sourced from ClinicalTrials.gov (NCT04826900). 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.