Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

NCT02755415 | Unknown DMC

• 1 other identifier: CMUH105-REC1-037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

Conditions

Stroke

Keywords

Rehabilitation; Robotic; Gait; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice

  15-20 minutes

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index

  10-15 minutes

• EuroQol five dimensions questionnaire (EQ-5D)

  10-15 minutes

• Resting muscle tone

  10 minutes

• Resting muscle elasticity

  10 minutes

• Six minute walk test

  6 minutes

Study Arms (2)

Static Standing Table Training

ACTIVE COMPARATOR

Patients in this group will receive standard hospital based rehabilitation as well as static standing table training

Other: Static Standing Table

Robotic Gait Training

EXPERIMENTAL

Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training

Device: HIWIN Robotic Gait Training System

Interventions

HIWIN Robotic Gait Training System DEVICE

HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training

Robotic Gait Training

Static Standing Table OTHER

As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position

Static Standing Table Training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the age of 20-80 years;
• Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
• Paresis of a lower limb;
• Ability to walk for only a few meters either with or without aid.

You may not qualify if:

• Deemed by a physician to be medically unstable;
• Other prior musculoskeletal conditions that affected gait capacity;
• Co-existence of other neurological diseases;
• Cognitive impairments that would impact on the safe participation in the study (MMSE\<23)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 408, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 28, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)