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Clinical Trials/NCT06258538
NCT06258538
Recruiting
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country87 target enrollmentJune 1, 2024
ConditionsStroke Patients

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Patients
Sponsor
Chang Gung Memorial Hospital
Enrollment
87
Locations
1
Primary Endpoint
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
December 31, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The upper-extremity subscale of FMA will be used to assess sensorimotor impairment. The FMA-UE includes 33 items assessing movements, reflexes, and coordination of upper limbs. Each item is measured on a 3-point ordinal scale and the total score ranges from 0 to 66 . A higher score indicates better motor function. The reliability and validity of the Fugl-Meyer Assessment are well established

Motor Activity Log (MAL)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The MAL falls within the activity and participation domains of ICF framework. It is a semi-structured interview for stroke patients to assess the amount of use (MAL-AOU) and quality of movement (MAL-QOM) of their affected arm and hand during 30 activities of daily living. The score of each activity ranges from 0 to 5, and higher scores represent more frequently used or higher quality of movement. The MAL has good validity, reliability, and responsiveness in patients with stroke

Medical Research Council scale (MRC)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The MRC is an ordinal scale assessing muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates greater muscle strength. The reliability of MRC was good to excellent in stroke patients

Grip and pinch strength

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The Jamar dynamometer is a standard, accurate, adjustable-handle tool specifically for measuring grip and pinch strength . Participants are asked to perform tasks under unilateral and bilateral conditions. In the unilateral condition, participants are asked to exert only with their paretic hands; in the bilateral condition, participants are asked to exert with both hands. Three trials will be taken at each assessment, and the average of three trials will be documented.

Wolf Motor Function Test (WMFT)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The WMFT assesses upper extremity motor ability by measuring the performance time (WMFT-Time) and functional ability rating scale (WMFT-FAS) in required task. Participants were timed and rated by using a 6-point ordinal scale. The WMFT is valid and reliable on assessing motor function in stroke patients

Nottingham Extended Activities of Daily Living Scale (NEADL):

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The NEADL is a measure of independence in 4 areas of daily life, including mobility, kitchen, domestic, and leisure activities. It includes 22 items, and each item is measured on a 4-point scale. The total score ranges from 0 to 66 and a higher score indicates better daily functional ability. The psychometric properties of the NEADL have been well established.

Mini-Mental State Examination (MMSE)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The MMSE is a 30-point questionnaire that is the most commonly used brief screening tool for detecting cognitive impairment. Higher values represent better cognitive functioning. The MMSE has good psychometric properties for identifying cognitive impairment

Modified Ashworth scale of muscle spasticity (MAS)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The MAS is a 6-point ordinal scale assessing muscle tone, where higher scores represent spasticity. The MAS scores of proximal and distal arm muscles will be examined. The MAS has good validity and reliability

Stroke Impact Scale Version 3.0 (SIS 3.0)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items grouped into 8 domains (strength, hand function, ADL/instrumental ADL, mobility, communication, emotion, memory and thinking, and participation/role function). The participants will be asked to rate each item on a 5-point Likert scale for the perceived difficulty in completing the task. An extra question will be asked to evaluate the participant's self-perceived overall recovery from stroke. The SIS 3.0 has satisfactory psychometric properties in stroke patients

The stroke self-efficacy questionnaires (SSEQ):

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The SSEQ measures an individual's confidence in relation to functional performance and self-management after stroke. It includes 13 items, and each item is rated on a 10-point scale from 0 (not at all confident) to 10 (very confident). The reliability and validity of the SSEQ are well established

Revised Nottingham Sensory Assessment (rNSA)

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The rNSA will be used to evaluate changes in sensation. It equips with various sensory modalities to assess tactile sensation, proprioception, and stereognosis of different segments of the body . Scoring of rNSA is based on a 3-point ordinal scale (0-2), with a lower score suggesting greater sensory impairment. The psychometric properties have been established in stroke patients

Daily Living Self-Efficacy Scale (DLSES):

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The DLSES measures self-efficacy of daily functioning, including psychosocial functioning and activities of daily living. The scale consists of 12 items, and each item is measured on a 100-point scale with 10-unit intervals (0 = cannot do at all, 100 = highly certain can do). A higher score indicates a higher level of self-efficacy. The DLSES is a psychometrically sound measure of self-efficacy in stroke survivors

Functional Abilities Confidence Scale (FACS):

Time Frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention

The FACS measures the degree of selfefficacy and confidence when the participants perform various movements and postures. It consists of 15 questions scoring from 0% (not confidence at all) to 100% (fully confidence). A higher score indicates higher confidence in performing the movements. The psychometric properties are good

Study Sites (1)

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