Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke

NCT ID: NCT05837975

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2024-03-15

Brief Summary

Background: Although rehabilitation activities, including physical therapy, are known to be beneficial for stroke patients, many patients still have poor walking function, especially after the acute phase of three months, where the recovery of lower limb walking ability through traditional rehabilitation therapy gradually decreases, requiring alternative approaches. Exoskeleton robots appear to provide benefits for stroke patients by providing exercise guidance, thus improving their independent gait endurance and stair climbing ability. For stroke patients who cannot continue to improve through general rehabilitation and have ongoing mobility difficulties, exoskeletons may be a potential solution. However, previous literature on the use of exoskeletons to assist gait training has had mixed results, with one major reason being that the frequency of use is too low or the duration of use is too short, due to the high cost and inconvenience of travel to medical institutions. Therefore, it is necessary to find ways to enable patients to use them frequently and for a long period.

Method: investigators designed a non-blinded, randomized crossover trial to observe the potential benefits of using the device at home for one month. Patients were randomly divided into two groups, one receiving traditional rehabilitation first and the other using the exoskeleton first. There were four time points for testing: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.

The testing involved executing a 6-minute walk test, timed up and go test, and a 10-step stair test (up and down) both with and without the device. An electronic software app was used to record daily usage time to determine the quantity and degree of home use.

Analysis: Repeated measures ANOVA models were used to analyze the effects and correlations of the experiment. The effects of the duration/frequency of use on dosage were also analyzed.

Conditions

Stroke; Exoskeleton

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FREE Walk Exoskeleton vs Traditional Rehabilitation for Stroke Patients

Participants in this arm will receive one month of traditional rehabilitation followed by one month of using the exoskeleton at home.

Group Type: EXPERIMENTAL

FREE Walk Exoskeleton

Intervention Type: DEVICE

Using a robotic exoskeleton to help with lower limb activities that are difficult due to neurological diseases. Used at home for individual patient training.

Traditional Rehabilitation

Intervention Type: OTHER

Traditional rehabilitation refers to the use of conventional therapeutic methods.

Traditional Rehabilitation vs FREE Walk Exoskeleton for Stroke Patients

Arm Description: Participants in this arm will receive one month of using the exoskeleton at home followed by one month of traditional rehabilitation.

Group Type: EXPERIMENTAL

FREE Walk Exoskeleton

Intervention Type: DEVICE

Using a robotic exoskeleton to help with lower limb activities that are difficult due to neurological diseases. Used at home for individual patient training.

Traditional Rehabilitation

Intervention Type: OTHER

Traditional rehabilitation refers to the use of conventional therapeutic methods.

Interventions

FREE Walk Exoskeleton

Using a robotic exoskeleton to help with lower limb activities that are difficult due to neurological diseases. Used at home for individual patient training.

Intervention Type: DEVICE

Traditional Rehabilitation

Traditional rehabilitation refers to the use of conventional therapeutic methods.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with first-time stroke, with onset time within 1 month to 2 years from the time of recruitment, and all participants must sign an informed consent form.

2. Patients must have independent walking ability, with or without cane.

3. Lower limb muscle tone Modified Ashworth Scale <3.

4. Able to perform a 25-meter walking test and a 10-step stair test without assistance from others.

5. Cognitive function Mini-Mental State Examination > 23 points.

Exclusion Criteria

1. Combined with other central nervous system problems, such as brain tumors or spinal cord injuries.

2. Clearly, lower limb joint diseases that cannot achieve complete hip, knee, and ankle joint activity are not excluded, but mild joint activity limitations caused by stroke are not excluded.

3. Skin diseases that are not suitable for contact with exoskeleton devices.

4. Unable to cooperate with the two-month research plan.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, ROC, Taiwan

Countries

Taiwan

Other Identifiers

202319

Identifier Type: -

Identifier Source: org_study_id