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Chronic StrokeNCT03624153

The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients

A study testing Robotic-assisted intervention and Conventional rehabilitation intervention in people with Chronic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Chronic Stroke
What is being tested?
Robotic-assisted intervention and Conventional rehabilitation intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteTaiwan
Study dates
30 Jul 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan City, 333

Other trials in Taiwan

About this study

Official title: 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

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.

Read the detailed description

The purpose of this study was to 1) examine the effects of EMG-driven robot-assisted intervention, and 2) examine whether the robot-assisted therapy is as effective as conventional intervention. The study was conducted using a randomized, two-period crossover design. Participants were randomly assigned to group 1 or group 2 using a computer-generated list. Participants in group 1 received 12 sessions of robot-assisted intervention first, followed by a one-month washout period, and then received 12 sessions of conventional intervention. Participants in group 2 received 12 sessions of conventional intervention first, followed by a one-month washout period, and then received 12 sessions of robot-assisted intervention. Outcome measures were performed before the intervention, after the first 12-session intervention, and after the second 12-session intervention.

Conditions
Chronic Stroke
Being tested
Robotic-assisted intervention, Conventional rehabilitation intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic-assisted interventionBehavioural

    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.

  • Conventional rehabilitation interventionBehavioural

    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.

Study groups in NCT03624153
Study groupRoleWhat they receive
Robotic-assisted interventionExperimental70 minutes Robotic-assisted intervention.
Receives: Behavioral: Robotic-assisted intervention
Conventional interventionActive comparator70 minutes conventional rehabilitation.
Receives: Behavioral: Conventional rehabilitation intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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)

  1. Change scores of Mini-Mental State Exam (MMSE)

    The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.

    Measured: 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

  2. Change scores of Jamar hand dynamometer

    The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. Excellent concurrent validity of the Jamar hand dynamometer is reported. The Jamar hand dynamometer measure the grip-strength. The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb. Higher value represent a greater grip-strength.

    Measured: 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

  3. Change scores of stroke self-efficacy questionnaire (SSEQ)

    the Stroke Self-Efficacy Questionnaire (SSEQ) , a questionnaire developed to measure the most relevant self-efficacy and self-management domains specific to the stroke population. It contains 13 items that are rated on a 0 - 10 scale, with higher scores indicating greater levels of self-efficacy. Questionnaire includes a range of relevant functional tasks such as walking, getting comfortable in bed, as well as some self-management tasks.

    Measured: 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

  4. Change scores of Modified Ashworth Scale (MAS)

    The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Higher score indicates higher muscle tone. Investigators will assess the MAS scores of UE muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors. The validity and reliability of MAS for patients with stroke were established to be adequate to good.

    Measured: 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

  5. Change scores of Active Range of Motion (AROM)

    Patient performs the exercise to move the joint without any assistance to the muscles surrounding the joint.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study start30 Jul 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624153
Sponsor's protocol ID
201701543B0
Status last verified
Jan 2020
First submitted
7 Aug 2018
Last updated
17 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35034664

Questions about this trial

What is this clinical trial studying?

A study testing Robotic-assisted intervention and Conventional rehabilitation intervention in people with Chronic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change scores of Fugl-Myer Assessment (FMA) (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.

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