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

Not Applicable

Recruiting

• Conditions: Stroke Rehabilitation

• Registration Number: NCT05492175
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Detailed Description

Robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. The proximal priority and distal priority robotic priming techniques may bring differential effects. This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.

Study Timeline

• Study Start: 2022-02-17
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks	Baseline, 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.
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Functional Independence Measure (FIM)	Baseline, 6 weeks, and 18 weeks	1. The FIM consists of 18 items grouped into 6 sub-scales, including self-care, sphincter control, transfer, locomotion, communication, and social cognition.; 2. Each item is rated from 1 (full assistance) to 7 (full independence), according to the level of support required to perform the tasks.; 3. A higher score (maximum score of 126) indicates a lower disability.
Medical Research Council scale (MRC)	Baseline, 6 weeks, and 18 weeks	1. MRC measures muscle power of the affected arm and is scored on a 6-point ordinal scale (0 = no contraction, 5 = resisted to maximal strength, full power compared with the unaffected side); 2. The higher score means the greater muscle power.
The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)	Baseline, 6 weeks, and 18 weeks	1. Accelerometry is used to measure human movement. These devices record patterns of motion and non-motion.; 2. All participants will be asked to wear the devices for 3 consecutive days before and after the intervention.; 3. .The accelerometer will record the number of movements per minute, and the mean counts of movements per minute will be calculated.; 4. The higher mean counts of movements per minute means the more activity of arm.
Stroke Self-Efficacy Questionnaire (SSEQ)	Baseline, 6 weeks, and 18 weeks	1. The SSEQ will be used to gauge participants' confidence in their functional performance after stroke.; 2. It includes 13 items and gives an overview of the factors that influence functional performance.; 3. Each item will be assigned according to the perceived confidence rating on the scale of 0 (no confidence at all) to 10 (full confidence).; 4. The higher summed score means the more confidence of participant.
Adverse events (pain and fatigue)	through study completion, an average of 18 weeks	1. Self-reported fatigue and pain severity will be evaluated using the 10-cm vertical line in the Face Rating Scale for adverse effects.; 2. The participants will rate the level of their pain and fatigue after the intervention on an 11-point ordinal scale (0 = no pain/fatigue; 10 = the most severe pain/fatigue).; 3. The higher score means the more pain or fatigue of participant.

Trial Locations

Locations (4)

Feng Yuan Hospital, Ministry of Health and Welfare; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Municipal Wan Fang Hospital; 🇨🇳 Taipei, Taiwan

Taipei Tzu Chi Hospital; 🇨🇳 Taipei, Taiwan