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

Chang Gung Medical Foundation

Status: Completed

Conditions: Stroke; Central Nervous System Diseases; Cerebrovascular Disorders

Treatments: Behavioral: Digital Action Observation Therapy (Digital AOT); Behavioral: Digital Mirror Therapy (Digital MT); Behavioral: Conventional Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04441190

201901885A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Digital Action Observation Therapy (Digital AOT)

Experimental group

Description:

The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.

Treatment:

Behavioral: Digital Action Observation Therapy (Digital AOT)

Digital Mirror Therapy (Digital MT)

Experimental group

Description:

The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.

Treatment:

Behavioral: Digital Mirror Therapy (Digital MT)

Conventional Occupational Therapy

Active Comparator group

Description:

The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.

Treatment:

Behavioral: Conventional Occupational Therapy