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

Stroke Patients Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258538
• Other study ID #: 202301367B0
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Yu-Wei Hsieh, ScD
• Phone: Phone: #886 886-3-2118800
• Email: ywhlab.ra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Stroke
• Stroke Patients

Intervention

Device:
• Robots can aid in distal UE rehabilitation through exoskeleton (EXO)
Exoskeleton robot-assisted therapy Each EXO robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Hand of Hope (HOH) robotic hand system . HOH is an exoskeleton type of robot that is worn on the dorsal side of the impaired hand with 2 surface EMG sensors attached to the extensor digitorum and flexor digitorum superficialis.
• End-effector robot-assisted therapy (EE)
Each EE robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Amadeo robotic system. Amadeo is an end-effector robot with 5 finger slides, which are attached to the fingertips and the thumb via magnetic finger pads. The integrated sensor for each finger allows the robot system to provide patients with real-time visual feedback of finger strengths and range of motion

Behavioral:
• Unilateral task-oriented therapy
The therapy will focus on task-oriented therapy with the affected UE and the training tasks involve proximal or distal UE movement, such as ringing a bell, picking up coins, grasping and releasing various cups, and other functional movements involved in daily activities. The level of challenge will be adapted according to patient ability and improvement during training.
• Bilateral task-oriented therapy
The functional training tasks emphasize UE movements (gross or fine motor tasks) involved in daily activities but focus on both UEs moving synchronously, such as opening 2 closet doors, grasping and releasing 2 towels, wiping the table with 2 hands, and so on. The activities can also be graded in terms of difficulty and task requirements, according to the impairment level and the progression of the UE of each participant.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memotial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination (MMSE)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Modified Ashworth scale of muscle spasticity (MAS)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Grip and pinch strength	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.	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Medical Research Council scale (MRC)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Revised Nottingham Sensory Assessment (rNSA)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Wolf Motor Function Test (WMFT)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Motor Activity Log (MAL)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Nottingham Extended Activities of Daily Living Scale (NEADL):	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.	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Stroke Impact Scale Version 3.0 (SIS 3.0)	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	The stroke self-efficacy questionnaires (SSEQ):	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Daily Living Self-Efficacy Scale (DLSES):	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention
Primary	Functional Abilities Confidence Scale (FACS):	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	baseline , after the completion of the 18-session intervention , and 3 month after intervention