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

NCT06258538 | Recruiting

• 1 other identifier: 202301367B0
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Patients

Keywords

Stroke rehabilitation; distal upper extremity

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

distal robot-assisted and task-oriented therapy

EXPERIMENTAL

Participants in the Circuit group received interventions for 20-min exoskeleton(EXO) and 20-min end-effector(EE) robot-assisted therapy, followed by 20-min uni- and 20-min bi- task-oriented therapy/session, 3 sessions/week for 6 consecutive weeks.

Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO); Device: End-effector robot-assisted therapy (EE); Behavioral: Unilateral task-oriented therapy; Behavioral: Bilateral task-oriented therapy

distal robot-assisted therapy alone

EXPERIMENTAL

Participants in the Robot group received interventions for 40-min exoskeleton(EXO) and 40-min end-effector(EE) robot-assisted therapy/session, 3 sessions/week for 6 consecutive weeks.

Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO); Device: End-effector robot-assisted therapy (EE)

task-oriented therapy alone

ACTIVE COMPARATOR

Participants in the task-oriented therapy(TOT) group received interventions for 40-min uni- and 40-min bi- task-oriented therapy/session, 3 sessions/week for 6 consecutive weeks.

Behavioral: Unilateral task-oriented therapy; Behavioral: Bilateral task-oriented therapy

Interventions

End-effector robot-assisted therapy (EE) DEVICE

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

distal robot-assisted and task-oriented therapy; distal robot-assisted therapy alone

Unilateral task-oriented therapy BEHAVIORAL

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.

distal robot-assisted and task-oriented therapy; task-oriented therapy alone

Bilateral task-oriented therapy BEHAVIORAL

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.

distal robot-assisted and task-oriented therapy; task-oriented therapy alone

Robots can aid in distal UE rehabilitation through exoskeleton (EXO) DEVICE

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.

distal robot-assisted and task-oriented therapy; distal robot-assisted therapy alone

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memotial Hospital

Taoyuan District, Taoyuan, 3333, Taiwan

RECRUITING

Central Study Contacts

Yu-Wei Hsieh, ScD

CONTACT

Phone: #886 886-3-2118800; ywhlab.ra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

TW (1)