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

Stroke Clinical Trial

Official title:

Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke : a Randomized, Cross-over Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837975
• Other study ID #: 202319
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: January 2024
• Source: Taipei Hospital, Ministry of Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.

Other:
• Traditional Rehabilitation
Traditional rehabilitation refers to the use of conventional therapeutic methods.

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Ministry of Health and Welfare	New Taipei City	ROC

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	final distance walked by the 6-minute walk test	Unit in meters, used to evaluate gait function and endurance. Participants walk along a 30-meter walkway, turning back within 6 minutes and recording the total distance covered at the end. Patients are allowed to rest during the test but not run. A higher score (walking distance) indicates better gait and endurance.This range overlaps with data reported in other populations.	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.
Primary	Time difference of Timed up and go' test (TUG)	The TUG test (time measured in seconds) is a common clinical test for mobility function, using the 3-meter TUG test and following the procedure of Podsiadlo and Richardson's standards. The method involves asking the patient to sit on a straight-backed chair, then stand up, walk three meters forward at their usual pace, turn around, and return to sit on the chair. The total time is recorded with a stopwatch. The test is repeated five times. For this test, a lower score (time to complete) means better overall mobility.	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.
Primary	Time difference of 10-step stair test	Timed Stair Test(TST) is a timed test measured in seconds, where the participant ascends and descends 10 steps of a staircase. The time taken to ascend(TSTup) and descend(TSTdn) is measured separately using a stopwatch. A lower score on this test indicates better stair climbing performance.	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.