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

NCT05825144 | Unknown

• 1 other identifier: CF21277A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke Sequelae

Keywords

robotic rehabilitation; stroke; quality of life; walking speed

Outcome Measures

Primary Outcomes (4)

• Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)

  4 weeks

• Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)

  4 weeks

• Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)

  12-item short form survey (SF-12): scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

  4 weeks

• Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)

  tested by isokinetic dynamometer

  4 weeks

Study Arms (2)

Robotic group

EXPERIMENTAL

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

Device: Robotic exoskeleton-assisted gait rehabilitation

Control group

ACTIVE COMPARATOR

This group receives conventional rehabilitation alone.

Other: Conventional rehabilitation

Interventions

Robotic exoskeleton-assisted gait rehabilitation DEVICE

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

Robotic group

Conventional rehabilitation OTHER

Regular post-stroke rehabilitation

Control group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuan-Yang Cheng, Dr.

CONTACT

+886-4-2359-2525; yycheng@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 24, 2023
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)