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Completed

NCT Number: NCT04441190

Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy

The specific study aims will be:

1. To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT). 2. To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback. 3. To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial. 4. To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Hospital, Ministry of Health and Welfare, New Taipei City, Taiwan

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About this study

Phase I: Multi-mode stroke rehabilitation (MSR) System Development & Usability Testing

Ten patients with stroke and 4 certified occupational therapists were recruited in this phase I study. During the pilot testing, each stroke patient will try to use each training mode of digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the patients and the therapists will be asked to complete the System Usability Scale and a self-designed questionnaire to assess the user experience and perspective about this new MSR system and their view of its suitability for stroke patients.

Phase II: Validation of Clinical Treatment Efficacy

This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention. An estimated 60 patients with stroke will be recruited to participate in this phase II study. Each participant will receive a total of 15 training sessions (60 minutes per session) for 3 to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after treatment (the fourth week), and at 1 month follow-up after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing

For stroke patients

Inclusion criteria

  • diagnosed as having a unilateral stroke;
  • aged from 20 to 80 years;
  • a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60;
  • able to follow the instructions and able to provide user feedback verbally;
  • without aphasia and neglect

For therapists

Inclusion criteria

  • holding an occupational therapist license

Phase II: Validation of Clinical Treatment Efficacy

Inclusion criteria

  • diagnosed as having a unilateral stroke;
  • at least 6 months after stroke onset;
  • aged from 20 to 80 years;
  • a baseline score of FMA in a range of 20 to 60;
  • able to follow the study instructions;
  • capable of participating in therapy and assessment sessions

Exclusion criteria

  • global or receptive aphasia,
  • severe neglect,
  • major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain

Treatment and study plan

Digital Action Observation Therapy (Digital AOT)

Behavioral

The participants will be asked to observe videos and then practice what the participants observed.

Digital Mirror Therapy (Digital MT)

Behavioral

The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.

Conventional occupational therapy

Behavioral

The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.

Primary outcomes

  1. Change scores of Fugl-Meyer Assessment

    Time frame: baseline, 4 weeks, 2 months

    The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.

  2. Change scores of Movement Imagery Questionnaire-Revised, Second Edition

    Time frame: baseline, 4 weeks, 2 months

    The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.

Secondary outcomes

  1. Change scores of Chedoke Arm and Hand Activity Inventory

    Time frame: baseline, 4 weeks, 2 months

    The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.

  2. Change scores of Box and Block Test

    Time frame: baseline, 4 weeks, 2 months

    The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.

  3. Change scores of Revised Nottingham Sensory Assessment

    Time frame: baseline, 4 weeks, 2 months

    The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.

  4. Change scores of Barthel Index

    Time frame: baseline, 4 weeks, 2 months

    The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.

  5. Change scores of Motor Activity Log

    Time frame: baseline, 4 weeks, 2 months

    The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.

  6. Change scores of the health state of EQ-5D-5L

    Time frame: baseline, 4 weeks, 2 months

    The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.

  7. Change scores of the visual analogue scale (VAS) of EQ-5D-5L

    Time frame: baseline, 4 weeks, 2 months

    The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.

  8. Change of joint angles of OPAL wearable sensors

    Time frame: baseline, 4 weeks, 2 months

    The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint angles. Joint angles of the shoulder, elbow, and wrist will be calculated.

  9. Change of joint velocity of OPAL wearable sensors

    Time frame: baseline, 4 weeks, 2 months

    The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint velocity. The angular velocity of shoulder, elbow, and wrist will be also collected.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2020
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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