Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke

NCT ID: NCT04002076

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-07

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to investigate the effects of robot-assisted hand with visual feedback intervention on cortical excitability, brain structure, spasiticity, gross and fine motor of upper limb and hand in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: robot-assisted hand combined with traditional occupational therapy group (10), only traditional occupational therapy group (10).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be randomized allocated to two groups: robot-assisted hand combined with traditional occupational therapy (OT) group and traditional OT group. All participants underwent six weeks, 3 sessions per week, and 60 minutes per session training program. Motor Evoked Potential (MEP), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Box and Block Test (BBT) and Purdue Pegboard Test (PPT) will be assessed before and after intervention in all participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot-assisted hand combined with occupational therapy

Ten participants in group A will undergo robot-assisted hand (with visual feedback) combined with occupational therapy. They will receive 60 minutes a day and 3 days a week robot-assisted hand and occupational therapy for six weeks.

Group Type EXPERIMENTAL

Robot-assisted hand combined with occupational therapy

Intervention Type BEHAVIORAL

Robot-assisted hand group contains 15 minutes of grasp and release motion, 15 minutes of visual feedback training and 30 minutes traditions occupational therapy. Traditional occupational therapy includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Traditional occupational therapy

Another 10 participants allocated to the group B will receive 60 minutes a day and 3 days a week traditional occupational therapy for six weeks.

Group Type ACTIVE_COMPARATOR

Traditional occupational therapy

Intervention Type BEHAVIORAL

Occupational therapy contains 60 minutes of traditional occupational therapy, which includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot-assisted hand combined with occupational therapy

Robot-assisted hand group contains 15 minutes of grasp and release motion, 15 minutes of visual feedback training and 30 minutes traditions occupational therapy. Traditional occupational therapy includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Intervention Type BEHAVIORAL

Traditional occupational therapy

Occupational therapy contains 60 minutes of traditional occupational therapy, which includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Mini-Mental State Examination score is above 23
2. A first-ever stroke with unilateral hemiplegia or hemiparesis.
3. Medical and psychological condition is stable.

Exclusion Criteria

1. Balance and walking ability affected by other neurological problems
2. Functional performance affected by medication or medical condition 3 Unable to tolerate rehabilitation.

4\. Severe hearing or visual problem. 5. Having pacemaker.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lai chien hung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical university Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chien-Hung Lai, MD PhD

Role: CONTACT

886-2-27372181 ext. 3538

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chien-Hung Lai, MD PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N201904042

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hand Rehabilitation Study for Stroke Patients
NCT03148106 ACTIVE_NOT_RECRUITING NA