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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441190
• Other study ID #: 201901885A3
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 31, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Cerebrovascular Disorders
• Nervous System Diseases
• Stroke

Intervention

Behavioral:
• Digital Action Observation Therapy (Digital AOT)
The participants will be asked to observe videos and then practice what the participants observed.
• Digital Mirror Therapy (Digital MT)
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
• Conventional Occupational Therapy
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Ministry of Health and Welfare	New Taipei City
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Fugl-Meyer Assessment	The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.	baseline, 4 weeks, 2 months
Primary	Change scores of Movement Imagery Questionnaire-Revised, Second Edition	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.	baseline, 4 weeks, 2 months
Secondary	Change scores of Chedoke Arm and Hand Activity Inventory	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.	baseline, 4 weeks, 2 months
Secondary	Change scores of Box and Block Test	The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.	baseline, 4 weeks, 2 months
Secondary	Change scores of Revised Nottingham Sensory Assessment	The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.	baseline, 4 weeks, 2 months
Secondary	Change scores of Barthel Index	The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.	baseline, 4 weeks, 2 months
Secondary	Change scores of Motor Activity Log	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.	baseline, 4 weeks, 2 months
Secondary	Change scores of the health state of EQ-5D-5L	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.	baseline, 4 weeks, 2 months
Secondary	Change scores of the visual analogue scale (VAS) of EQ-5D-5L	The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.	baseline, 4 weeks, 2 months
Secondary	Change of joint angles of OPAL wearable sensors	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.	baseline, 4 weeks, 2 months
Secondary	Change of joint velocity of OPAL wearable sensors	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.	baseline, 4 weeks, 2 months