NCT03624153

Brief Summary

The purpose of this study is to examine the effects of the EMG-driven exoskeleton hand robotic training device on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in brain injury patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 17, 2021

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

August 7, 2018

Last Update Submit

May 13, 2021

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (4)

  • Change scores of Fugl-Myer Assessment (FMA)

    The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of Wolf Motor Function Test (WMFT)

    The WMFT is a reliable method to evaluate the UE motor ability in patients after stroke. The WMFT contains 15 function-based tasks and 2 strength-based tasks. The time (WMFT-time) and the functional ability (WMFT-quality) for an individual to complete the tasks will be recorded. A shorter WMFT-time and a larger WMFT-quality score indicate a faster movement and better quality of movement, respectively.

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of Motor Activity Log (MAL)

    The MAL will be used to assess the amount of use (AOU) and quality of movement (QOM) of the paretic UE. The MAL is a semi-structured interview that tests object manipulation and gross motor activities of daily living. The psychometric properties of MAL have been well-established, and a higher MAL score indicates better movement quality.

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of Action Research Arm Test (ARAT)

    The Action Research Arm Test (ARAT) evaluates 19 tests of arm motor function, both distally and proximally. Each test is given an ordinal score of 0, 1, 2, or 3, with higher values indicating better arm motor status. The total ARAT score is the sum of the 19 tests, and thus the maximum score is 57.

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

Secondary Outcomes (5)

  • Change scores of Mini-Mental State Exam (MMSE)

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of Jamar hand dynamometer

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of stroke self-efficacy questionnaire (SSEQ)

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of Modified Ashworth Scale (MAS)

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

  • Change scores of Active Range of Motion (AROM)

    Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline

Study Arms (2)

Robotic-assisted intervention

EXPERIMENTAL

70 minutes Robotic-assisted intervention.

Behavioral: Robotic-assisted intervention

Conventional intervention

ACTIVE COMPARATOR

70 minutes conventional rehabilitation.

Behavioral: Conventional rehabilitation intervention

Interventions

Robotic-assisted interventionBEHAVIORAL

Participants received the 12-session robot-assisted intervention 3 sessions a week for 4 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.

Robotic-assisted intervention
Conventional rehabilitation interventionBEHAVIORAL

Participants received the 12-session conventional rehabilitation intervention 3 sessions a week for 4 consecutive weeks. The intervention consisted of warm up including range of motion exercise, and strengthening exercise followed by task-oriented training for activities of daily living.

Conventional intervention

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral stroke ≥ 3 months prior to study enrollment
  • Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score \<60
  • without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3)
  • Mini Mental State Exam (MMSE) score \> 24, indicating no serious cognitive impairment
  • between the ages of 20 and 75 years.

You may not qualify if:

  • histories of other neurological diseases such as dementia 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Related Publications (1)

  • Chen YW, Chiang WC, Chang CL, Lo SM, Wu CY. Comparative effects of EMG-driven robot-assisted therapy versus task-oriented training on motor and daily function in patients with stroke: a randomized cross-over trial. J Neuroeng Rehabil. 2022 Jan 16;19(1):6. doi: 10.1186/s12984-021-00961-w.

    PMID: 35034664DERIVED

Study Officials

  • Ching-Yi Wu

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 9, 2018

Study Start

July 30, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 17, 2021

Record last verified: 2020-01

Locations

TW(1)