search
Back to results

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

Primary Purpose

Stroke, Robotic Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exoskeleton ExoAthlet group
Lokomat Free-D group
Sponsored by
Antalya Bilim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private rehabilitation center in Istanbul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exoskeleton ExoAthlet group

Lokomat Free-D group

Arm Description

Outcomes

Primary Outcome Measures

Functional Independence Measure
: Participants' functional independence was assessed with the Turkish version of the Functional Independence Measure (FIM).17 FIM indicates the degree of independence of an individual in basic physical and cognitive activities in daily life. FIM consists of 18 questions and basically measures 2 parameters: 1) physical/motor function, 2) cognitive/cognitive function. Each item is scored at 7 levels (1-7), with 'level 1' representing full dependance and 'level 7' completely independence. The FIM total score is between 18-126 points. The higher the score an individual gets, the higher the level of independence means. FIM is the most preferred and used activity scale in the field of rehabilitation.
30-Second chair stand test
The physical functionality of the participants was assessed with the 30-Second chair stand test.18 The 30-second chair stand test (30-CST) is a measure of lower body strength and endurance. Participants were asked to sit in a standard-height chair (with a seat height of 43 cm) with arms crossed over the chest, then stand fully and sit down again as many times as possible within 30 s. In order to decrease the effect of learning, all tests began with three to five practices.
6- Minute walk test
The functional capacities of the participants were evaluated with the 6-Minute Walk Test (6MWT), which can determine the functional capacity of individuals with a single measurement in neurological diseases.19 In the study, a 30 m long straight line was divided into 3 m intervals and the total distance walked at the end of 6 minutes was calculated. Rest period of 10 minutes was given before the test. The importance of the distance to be walked was emphasized to the individuals participating in the study and they were asked to walk as fast as they could without running. At the end of the test, the distance that the individuals could walk was recorded in meters (m).
36-Item Short Form Health Survey
The quality of life of the participants was evaluated with the Turkish version of the Medical Outcomes 36-Item Short Form Health Survey (SF-36) scale.20 SF-36 is a 36-item self-assessment scale consisting of eight sub-parameters. This scale consists of Physical functioning, Role limitations: Physical/Emotional, Social functioning, Mental health, Vitality, General health perception sub-parameters. Each subscale is scored between 0-100. An increase in the score indicates an improvement in the quality of life.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
July 6, 2023
Sponsor
Antalya Bilim University
search

1. Study Identification

Unique Protocol Identification Number
NCT05937464
Brief Title
Effects of Robotic-Assisted Gait Training in Patients With Stroke (EoRAGTiPwS)
Acronym
EoRAGTiPwS
Official Title
Effects of Robotic-Assisted Gait Training on Functional Independence, Functional Capacity, and Quality of Life in Patients With Stroke: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Bilim University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton ExoAthlet group
Arm Type
Experimental
Arm Title
Lokomat Free-D group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exoskeleton ExoAthlet group
Intervention Description
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
Intervention Name(s)
Lokomat Free-D group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Independence Measure
Description
: Participants' functional independence was assessed with the Turkish version of the Functional Independence Measure (FIM).17 FIM indicates the degree of independence of an individual in basic physical and cognitive activities in daily life. FIM consists of 18 questions and basically measures 2 parameters: 1) physical/motor function, 2) cognitive/cognitive function. Each item is scored at 7 levels (1-7), with 'level 1' representing full dependance and 'level 7' completely independence. The FIM total score is between 18-126 points. The higher the score an individual gets, the higher the level of independence means. FIM is the most preferred and used activity scale in the field of rehabilitation.
Time Frame
At baseline
Title
30-Second chair stand test
Description
The physical functionality of the participants was assessed with the 30-Second chair stand test.18 The 30-second chair stand test (30-CST) is a measure of lower body strength and endurance. Participants were asked to sit in a standard-height chair (with a seat height of 43 cm) with arms crossed over the chest, then stand fully and sit down again as many times as possible within 30 s. In order to decrease the effect of learning, all tests began with three to five practices.
Time Frame
At baseline
Title
6- Minute walk test
Description
The functional capacities of the participants were evaluated with the 6-Minute Walk Test (6MWT), which can determine the functional capacity of individuals with a single measurement in neurological diseases.19 In the study, a 30 m long straight line was divided into 3 m intervals and the total distance walked at the end of 6 minutes was calculated. Rest period of 10 minutes was given before the test. The importance of the distance to be walked was emphasized to the individuals participating in the study and they were asked to walk as fast as they could without running. At the end of the test, the distance that the individuals could walk was recorded in meters (m).
Time Frame
At baseline
Title
36-Item Short Form Health Survey
Description
The quality of life of the participants was evaluated with the Turkish version of the Medical Outcomes 36-Item Short Form Health Survey (SF-36) scale.20 SF-36 is a 36-item self-assessment scale consisting of eight sub-parameters. This scale consists of Physical functioning, Role limitations: Physical/Emotional, Social functioning, Mental health, Vitality, General health perception sub-parameters. Each subscale is scored between 0-100. An increase in the score indicates an improvement in the quality of life.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Private rehabilitation center in Istanbul
City
Istanbul
State/Province
Antalya
ZIP/Postal Code
07190
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs