Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Patients

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memotial Hospital

Taoyuan, 3333, Taiwan

Location status: Recruiting

Location contact

Yu-Wei Hsieh, ScD

CONTACT

[email protected]

+886-3-2118800 ext. 3820

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

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.

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

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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 contacts

Contact information is provided by the study sponsor or research team.

Yu-Wei Hsieh, ScD

CONTACT

[email protected]

Phone: #886 886-3-2118800 ext. 3820

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.