NCT05837975

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Taipei Hospital, Ministry of Health and Welfare · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-05
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2023-05-01
• Last updated: 2024-11-20

Locations

1 site across 1 country: Taiwan