N/A
N=36
Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin Injection
Stroke · Hemiplegia, Spastic
Bottom Line
View on ClinicalTrials.gov: NCT03321097 ↗Enrolled (actual)
36
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Fugl-Meyer Assessment (FMA) — 3.45; 1.94 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- condensed RT group (Device); distributed RT group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment (FMA) |
3.45; 1.94 | — |
| PRIMARY Wolf Motor Function Test (WMFT)-Time |
-6.31; -7.89 | — |
| PRIMARY Modified Ashworth Scale (Masiero et al.) |
0.98; 1.07; 1.10; 1.43 | — |
| PRIMARY Wolf Motor Function Test (WMFT)-Function |
2.32; 2.20 | — |
| SECONDARY Canadian Occupational Performance Measure (COPM) |
5.60; 5.45; 5.94; 5.45 | — |
| SECONDARY Goal Attainment Scale (GAS) |
47.11; 51.83 | — |
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 between condensed and distributed robot-assisted training (RT) programs in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. According to the result of the investigator's ongoing study, the investigators found BoNT-A injection combined with robot-assisted training is recommended to enhance functional recovery for patients with spastic hemiplegic stroke. However, the optimal program as considering the RT frequency is unknown.
The aims of this study are to determine and compare the immediate and longer-term effects between condensed and distributed programs of RT following BoNT-A injection in subjects with spastic hemiplegic stroke .
Participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to either condensed or distributed RT groups post BoNT-A injection. Each training session included 40 minutes RT, followed by 40-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks, the distributed group 2 sessions per week, for 12 weeks. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale. Activity and participation measures include Wolf Motor Function Test, Motor Activity Log, and Canadian Occupational Performance Measure. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment, and 6-week follow-up. The investigators will also use the movement time of robot without powered assistance and surface EMG to determine the motor learning processes of patients receiving the two practice frequencies of RT.
This comparative efficacy study will be the first to examine and compare the motor learning processes and immediate and long-term effects between condensed and distributed RT post BoNT injection. The results may provide clinicians with the appropriate methods to scheduling RT following BoNT-A injection to improve upper limb functions for patients with hemiplegic spasticity stroke.
Eligibility Criteria
Inclusion Criteria
- clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- upper limb spasticity (modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon & Smith, 1987)
- initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, & Feussner, 1992; Fugl Meyer, Jaasko, & Leyman, 1975; Park, Wolf, Blanton, Winstein, & Nichols-Larsen, 2008)
- no serious cognitive impairment (i.e., Mini Mental State Exam score > 20) (Teng & Chui, 1987)
- age ≥ 18 years
- willing to provide written informed consent
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 4 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 (NCT03321097). 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.