Effects of Robotic-Assisted Gait Training in Patients With Stroke (EoRAGTiPwS)

NCT ID: NCT05937464

Last Updated: 2023-07-10

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-01-01

Brief Summary

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This study was conducted to examine effects of gait training with exoskeleton ExoAthlet and Lokomat Free-D on functional independence, functional capacity and quality of life in stroke patients.

Detailed Description

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The study included 32 patients who had stroke. Participants were randomized into two groups. Functional independence of patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet (ExoAtlet 1 model/2019, Russia), other group with Lokomat Free-D (Hocoma, Lokomat Pro Free-D model/2015, Switzerland). Participants were assessed at baseline and post-intervention.

Conditions

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Stroke, Robotic Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Exoskeleton ExoAthlet group

Group Type EXPERIMENTAL

Exoskeleton ExoAthlet group

Intervention Type OTHER

This group included 16 patients who had stroke. The patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet (ExoAtlet 1 model/2019, Russia). Participants were assessed at baseline and post-intervention.

Lokomat Free-D group

Group Type EXPERIMENTAL

Lokomat Free-D group

Intervention Type OTHER

This group included 16 patients who had stroke. The patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with Lokomat Free-D (Hocoma, Lokomat Pro Free-D model/2015, Switzerland). Participants were assessed at baseline and post-intervention.

Interventions

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Exoskeleton ExoAthlet group

This group included 16 patients who had stroke. The patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet (ExoAtlet 1 model/2019, Russia). Participants were assessed at baseline and post-intervention.

Intervention Type OTHER

Lokomat Free-D group

This group included 16 patients who had stroke. The patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with Lokomat Free-D (Hocoma, Lokomat Pro Free-D model/2015, Switzerland). Participants were assessed at baseline and post-intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between18-65 years old
* Patients who had a stroke at least three months ago
* Can independently ambulated

Exclusion Criteria

* Heart failure and rhythm disorder,
* Visual and cognitive problems,
* Neglect phenomenon (Neglect Syndrome),
* Cerebellar pathology,
* Any lower extremity surgery
* An additional neurological pathology that could prevent receiving a training program
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Bilim University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Private rehabilitation center in Istanbul

Istanbul, Antalya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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61351342/2021-66

Identifier Type: -

Identifier Source: org_study_id

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