Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients

NCT ID: NCT05825144

Last Updated: 2023-04-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.

Detailed Description

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Conditions

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Stroke Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Robotic group

This group receives conventional rehabilitation plus robotic exoskeleton-assisted gait rehabilitation.

Group Type EXPERIMENTAL

Robotic exoskeleton-assisted gait rehabilitation

Intervention Type DEVICE

Use a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation

Control group

This group receives conventional rehabilitation alone.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Regular post-stroke rehabilitation

Interventions

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Robotic exoskeleton-assisted gait rehabilitation

Use a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation

Intervention Type DEVICE

Conventional rehabilitation

Regular post-stroke rehabilitation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients aged from 30 to 80 years
* hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months

Exclusion Criteria

* with a significant history of pain or injury of lower limbs that affected their walking ability,
* with cardiopulmonary diseases that prohibited exercise training
* with impaired cognitive function
* unable to complete the timed up-and-go test
* able to complete the timed up-and-go test in \<20 seconds using walking device
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yuan-Yang Cheng, Dr.

Role: CONTACT

+886-4-2359-2525 ext. 3500

Facility Contacts

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Yuan-Yang Cheng, Dr.

Role: primary

+886-4-2359-2525 ext. 3500

Other Identifiers

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CF21277A

Identifier Type: -

Identifier Source: org_study_id

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