Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation

NCT05492175 | Recruiting

• 1 other identifier: 10-M-161
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.

Conditions

Stroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks

  1. The upper-extremity subscale of the FMA will be used to assess motor impairment. 2. There are 33 UE items that assess movements and reflexes of the shoulder/elbow/forearm, wrist, and hand, and coordination/speed. Each item is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). 3. The maximum score is 66, with a subscale score of 42 for the proximal part of the arms (shoulder/elbow) and 24 for the distal part of the arm (wrist/hand/coordination) 4. The higher summed score means the greater recovery of motor impairment.

  Baseline, 6 weeks, and 18 weeks

• Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks

  1.10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. 2.The total time is recorded in m/s 3.The lower total time means the greater recovery of walking speed.

  Baseline, 6 weeks, and 18 weeks

Secondary Outcomes (5)

• Medical Research Council scale (MRC)

  Baseline, 6 weeks, and 18 weeks

• The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)

  Baseline, 6 weeks, and 18 weeks

• Functional Independence Measure (FIM)

  Baseline, 6 weeks, and 18 weeks

• Stroke Self-Efficacy Questionnaire (SSEQ)

  Baseline, 6 weeks, and 18 weeks

• Adverse events (pain and fatigue)

  through study completion, an average of 18 weeks

Study Arms (3)

proximal-prioritized robotic practice plus kinetic exergaming group

EXPERIMENTAL

60 minutes per day, 3 days per week for 6 weeks

Other: robotic practice; Other: kinetic exergaming

distal-prioritized robotic practice plus kinetic exergaming group

ACTIVE COMPARATOR

60 minutes per day, 3 days per week for 6 weeks

Other: robotic practice; Other: kinetic exergaming

robotic practice plus conventional therapy group

ACTIVE COMPARATOR

60 minutes per day, 3 days per week for 6 weeks

Other: robotic practice; Other: conventional therapy

Interventions

robotic practice OTHER

According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.

distal-prioritized robotic practice plus kinetic exergaming group; proximal-prioritized robotic practice plus kinetic exergaming group; robotic practice plus conventional therapy group

kinetic exergaming OTHER

All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed.

distal-prioritized robotic practice plus kinetic exergaming group; proximal-prioritized robotic practice plus kinetic exergaming group

conventional therapy OTHER

Participants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The content of the functional tasks will be decided together by participants and therapists, such as picking up and putting down items in a box, lifting two soft drink bottles, and so on.

robotic practice plus conventional therapy group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a first ever-stroke≧3 months
• age range between 20 to 80 years
• baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
• no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale \< 3 at any joints)
• able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
• can maintain a step-standing position for at least 30 seconds
• can walk for at least 10 meters with or without device
• no participation in further experimental rehabilitation or drug studies during the duration of the project

You may not qualify if:

• acute inflammation and pain
• concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (4)

Feng Yuan Hospital, Ministry of Health and Welfare

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan

RECRUITING

Taipei Tzu Chi Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Keh-Chung Lin, Sc.D

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keh-Chung Lin, Sc.D

CONTACT

+886-3366-8180; kehchunglin@ntu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: August 8, 2022
• Study Start: February 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)