Clinical trial NCT06258538: Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke
Official title: Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Patients
Keywords: Stroke rehabilitation
distal upper extremity
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study proposes a novel stroke rehabilitation approach for upper extremity training by firstly combining different types of distal robot-assisted and task-oriented therapy in a circuit training program. The program could enhance UE functions, improving daily function, decrease caregiver burden and lower medical expenses associated with long-term care. Professionals can use these findings to promote the application of clinically empirical research and better understand the effects and mechanisms of circuit training.


Eligibility criteria: Inclusion Criteria:

1. unilateral stroke ≥ 3 months onset
2. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56, indicating different levels of motor impairments ;
3. without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3 in proximal joints and modified Ashworth scale ≤2 in distal joints);
4. Mini Mental State Exam (MMSE) score \> 24, indicating no serious cognitive impairment;
5. between the ages of 20 and 75 years -

Exclusion Criteria:

1. histories of other neurological diseases such as dementia, Parkinson's disease, and peripheral polyneuropathy;
2. difficulties in following and understanding instructions such as global aphasia;
3. enroll in other rehabilitation or drug studies simultaneously;
4. receiving Botulinum toxin injections within 3 months. -

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Modified Ashworth scale of muscle spasticity (MAS)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Grip and pinch strength
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Medical Research Council scale (MRC)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Revised Nottingham Sensory Assessment (rNSA)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Wolf Motor Function Test (WMFT)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Motor Activity Log (MAL)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Nottingham Extended Activities of Daily Living Scale (NEADL):
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: The stroke self-efficacy questionnaires (SSEQ):
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Daily Living Self-Efficacy Scale (DLSES):
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
measure: Functional Abilities Confidence Scale (FACS):
timeFrame: baseline , after the completion of the 18-session intervention , and 3 month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memotial Hospital
Study officials:
References: