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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Stroke, Robotic Rehabilitation

Being tested

Exoskeleton ExoAthlet group, Lokomat Free-D group

Keywords

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

Medical subject headings

Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Exoskeleton ExoAthlet groupOther

  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.

• Lokomat Free-D groupOther

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: At baseline

2. 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.

   Measured: At baseline

3. 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).

   Measured: At baseline

4. 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.

   Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Jul 2023
2. Study start1 Jun 2021
3. Primary completion1 Sep 2021
4. Study completion1 Jan 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Stroke, Robotic RehabilitationStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.