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

NCT05937464 | Completed

• 1 other identifier: 61351342/2021-66
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Robotic Rehabilitation

Keywords

Stroke; Robotic Rehabilitation; Functional Independence; Functional Capacity; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Exoskeleton ExoAthlet group

EXPERIMENTAL

Other: Exoskeleton ExoAthlet group

Lokomat Free-D group

EXPERIMENTAL

Other: Lokomat Free-D group

Interventions

Exoskeleton ExoAthlet group OTHER

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.

Exoskeleton ExoAthlet group

Lokomat Free-D group OTHER

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.

Lokomat Free-D group

Eligibility Criteria

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

You may qualify if:

• Age between18-65 years old
• Patients who had a stroke at least three months ago
• Can independently ambulated

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Bilim University: lead

Study Sites (1)

Private rehabilitation center in Istanbul

Istanbul, Antalya, 07190, Turkey (Türkiye)

Location

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: July 10, 2023
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)