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

Effects of Robotic-Assisted Gait Training on Functional Independence, Functional Capacity, and Quality of Life in Patients With Stroke: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Robotic Rehabilitation
• Intervention / Treatment: Other: Exoskeleton ExoAthlet group; Other: Lokomat Free-D group

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya
    • Istanbul, Antalya, Turkey, 07190
      • Private rehabilitation center in Istanbul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exoskeleton ExoAthlet group	Other: Exoskeleton ExoAthlet group; 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.
Experimental: Lokomat Free-D group	Other: Lokomat Free-D group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline
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.	At baseline
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).	At baseline
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.	At baseline

Collaborators and Investigators

• Sponsor: Antalya Bilim University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Quality of Life; Functional Independence; Functional Capacity; Robotic Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 61351342/2021-66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No