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

Stroke Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492175
• Other study ID #: 10-M-161
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Keh-Chung Lin, Sc.D
• Phone: +886-3366-8180
• Email: kehchunglin[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

Other:
• robotic practice
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.
• kinetic exergaming
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.
• conventional therapy
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.

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks	The upper-extremity subscale of the FMA will be used to assess motor impairment.; 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).; 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); The higher summed score means the greater recovery of motor impairment.	Baseline, 6 weeks, and 18 weeks
Primary	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	Medical Research Council scale (MRC)	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); The higher score means the greater muscle power.	Baseline, 6 weeks, and 18 weeks
Secondary	The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)	Accelerometry is used to measure human movement. These devices record patterns of motion and non-motion.; All participants will be asked to wear the devices for 3 consecutive days before and after the intervention.; .The accelerometer will record the number of movements per minute, and the mean counts of movements per minute will be calculated.; The higher mean counts of movements per minute means the more activity of arm.	Baseline, 6 weeks, and 18 weeks
Secondary	Functional Independence Measure (FIM)	The FIM consists of 18 items grouped into 6 sub-scales, including self-care, sphincter control, transfer, locomotion, communication, and social cognition.; Each item is rated from 1 (full assistance) to 7 (full independence), according to the level of support required to perform the tasks.; A higher score (maximum score of 126) indicates a lower disability.	Baseline, 6 weeks, and 18 weeks
Secondary	Stroke Self-Efficacy Questionnaire (SSEQ)	The SSEQ will be used to gauge participants' confidence in their functional performance after stroke.; It includes 13 items and gives an overview of the factors that influence functional performance.; Each item will be assigned according to the perceived confidence rating on the scale of 0 (no confidence at all) to 10 (full confidence).; The higher summed score means the more confidence of participant.	Baseline, 6 weeks, and 18 weeks
Secondary	Adverse events (pain and fatigue)	Self-reported fatigue and pain severity will be evaluated using the 10-cm vertical line in the Face Rating Scale for adverse effects.; 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).; The higher score means the more pain or fatigue of participant.	through study completion, an average of 18 weeks