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

Primary Purpose

Stroke Rehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
robotic practice
kinetic exergaming
conventional therapy
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Feng Yuan Hospital, Ministry of Health and WelfareRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Municipal Wan Fang HospitalRecruiting
  • Taipei Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

proximal-prioritized robotic practice plus kinetic exergaming group

distal-prioritized robotic practice plus kinetic exergaming group

robotic practice plus conventional therapy group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Myoton Pro
Myoton provides digital palpation of superficial skeletal muscles. It also enables measurement not only of muscles, but also tendons, ligaments, even skin and other soft biological tissues. The Myoton Pro is a non-invasive measurement to characterize muscle tone, elasticity, and stiffness through calculating numerical parameters. Three trials will be recorded with an interval of 1 second, and the mean value will be calculated to represent the functional status of the muscles tested.
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.
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.
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.
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.

Full Information

First Posted
July 3, 2022
Last Updated
November 15, 2022
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05492175
Brief Title
Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
Official Title
Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
proximal-prioritized robotic practice plus kinetic exergaming group
Arm Type
Experimental
Arm Description
60 minutes per day, 3 days per week for 6 weeks
Arm Title
distal-prioritized robotic practice plus kinetic exergaming group
Arm Type
Active Comparator
Arm Description
60 minutes per day, 3 days per week for 6 weeks
Arm Title
robotic practice plus conventional therapy group
Arm Type
Active Comparator
Arm Description
60 minutes per day, 3 days per week for 6 weeks
Intervention Type
Other
Intervention Name(s)
robotic practice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
kinetic exergaming
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Secondary Outcome Measure Information:
Title
Medical Research Council scale (MRC)
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Myoton Pro
Description
Myoton provides digital palpation of superficial skeletal muscles. It also enables measurement not only of muscles, but also tendons, ligaments, even skin and other soft biological tissues. The Myoton Pro is a non-invasive measurement to characterize muscle tone, elasticity, and stiffness through calculating numerical parameters. Three trials will be recorded with an interval of 1 second, and the mean value will be calculated to represent the functional status of the muscles tested.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Stroke Self-Efficacy Questionnaire (SSEQ)
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Adverse events (pain and fatigue)
Description
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.
Time Frame
through study completion, an average of 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: acute inflammation and pain concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keh-Chung Lin, Sc.D
Phone
+886-3366-8180
Email
kehchunglin@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keh-Chung Lin, Sc.D
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feng Yuan Hospital, Ministry of Health and Welfare
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-Chung Lin, ScD
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-Chung Lin, ScD
Facility Name
Taipei Municipal Wan Fang Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-Chung Lin, ScD
Facility Name
Taipei Tzu Chi Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, Sc.D
Phone
+886 33668180
Email
kehchunglin@ntu.edu.tw

12. IPD Sharing Statement

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

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