Clinical trial NCT05837975: Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke
Official title: Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke : a Randomized, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Exoskeleton
Keywords: Subacute
Motor function
Robot
Walking assistance
Home mobility aid
Lead sponsor: Taipei Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: final distance walked by the 6-minute walk test
timeFrame: 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.
measure: Time difference of Timed up and go' test (TUG)
timeFrame: 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.
measure: Time difference of 10-step stair test
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
state: ROC
Study officials:
References: