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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HIWIN Robotic Gait Training System
Static Standing Table
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Robotic, Gait, Quality of Life

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Static Standing Table Training

Robotic Gait Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
EuroQol five dimensions questionnaire (EQ-5D)
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
Resting muscle tone
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Resting muscle elasticity
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Six minute walk test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Beck's depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

Full Information

First Posted
April 21, 2016
Last Updated
July 26, 2016
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02755415
Brief Title
Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
Official Title
Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Robotic, Gait, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Static Standing Table Training
Arm Type
Active Comparator
Arm Description
Patients in this group will receive standard hospital based rehabilitation as well as static standing table training
Arm Title
Robotic Gait Training
Arm Type
Experimental
Arm Description
Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training
Intervention Type
Device
Intervention Name(s)
HIWIN Robotic Gait Training System
Intervention Description
HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
Intervention Type
Other
Intervention Name(s)
Static Standing Table
Intervention Description
As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
15-20 minutes
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
Time Frame
10-15 minutes
Title
EuroQol five dimensions questionnaire (EQ-5D)
Description
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
Time Frame
10-15 minutes
Title
Resting muscle tone
Description
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Time Frame
10 minutes
Title
Resting muscle elasticity
Description
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Time Frame
10 minutes
Title
Six minute walk test
Description
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time Frame
6 minutes
Title
Beck's depression Inventory
Description
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Time Frame
7-10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
408
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, MD, MSc
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@gmail.com
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, MD, PhD, MSc
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, MD
First Name & Middle Initial & Last Name & Degree
Andy Chien, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will remain confidential and accessible to only the approved researchers

Learn more about this trial

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

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