The Effect of Robot-assisted Gait Training in Individuals With Chronic Stroke

NCT06746415 | Recruiting

• 1 other identifier: Biruni.Uni
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study was to investigate the effect of robot-assisted gait training on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke. For these purposes:-Improving gait and balance functions of patients with chronic stroke,-Increasing functional independence in daily life with walking trainings-Increase lower extremity muscle thickness with walking training, To investigate the effects of robot-assisted gait training on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke.-It is aimed to contribute to the literature in this field by transforming the results to be obtained as a result of the study into a scientific publication

Conditions

Chronic Stroke

Keywords

exercise; robotic gait training; balance; gait

Outcome Measures

Primary Outcomes (5)

• Fugl Meyer Lower Extremity Assessment:

  In this scale, reflexes, synergy-dependent or independent voluntary movement, coordination and speed are evaluated, with each item scoring Yazım alanları gerektiği kadar uzatılabilir 2 points. 0: Cannot complete movement/No active movement. 1: Partial movement. 2: Movement is completed/movements can be performed normally. The lowest clinically significant score in the Fugl-Meyer test is considered to be 6

  15 minutes

• Ten meter walk test

  For this test, a 16-meter walking track is created with starting and ending points and the test is completed without considering the first 3 and last 3 meters of this track. When the patient starts walking, the stopwatch is started after the first three meters and the stopwatch is stopped at the end of the tenth meter. After the patient walks the last 3 meters, walking is terminated. The completion time of the test is recorded in seconds

  5 minutes

• Berg Balance Scale

  The Berg Balance Scale (BBS) is a scale that includes 14 instructions and for each instruction, the patient's performance is observed and a score between 0-4 is given. A score of 0 is given when the patient cannot perform the activity at all, while a score of 4 is given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating impaired balance, 21-40 points indicating acceptable balance, and 41-56 points indicating good balance. The scale takes between 10 and 20 minutes to complete. It has been validated in patients with chronic stroke

  15 minutes

• Examination of muscle thickness by ultrasound

  The muscle thickness of the quadriceps and tibialis anterior muscles on the hemiplegic and intact side will be measured and recorded by ultrasound before and after treatment.

  10 minutes

• Gait Analysis with Kinovea

  Walking distances of 3 meters will be recorded with the camera to be placed on the sagittal. Colored marks will be placed on the right and left heels. The colored marks will be marked on the video and step lengths, walking speed and arm swing will be calculated with Kinovea motion analysis software. Several gait cycles will be recorded in the video and cadence (number of steps per minute), right and left step lengths will be expressed

  10 minutes

Secondary Outcomes (2)

• The Timed Up and Go Test

  5 minutes

• Stroke Specific Quality of Life Scale

  15 minutes

Study Arms (2)

Conventional Gait Group

ACTIVE COMPARATOR

Conventional walking training group will be given 20 minutes of NMES, 20 minutes of weight transfer, stretching, mobilization, bobath exercises and 20 minutes of parallel bar walking exercises.Patients in both groups will be treated 3 days a week, 1 hour a day for 6 weeks.

Other: Conventional Gait Training

Robotic Gait Group

EXPERIMENTAL

. The robot-assisted walking group will receive 20 minutes of NMES, 20 minutes of weight transfer, stretching,mobilization, bobath exercises and 20 minutes of robot-assisted walking exercises. Patients in both groups will be treated 3 days a week, 1 hour a day for 6 weeks.

Other: Robotic Gait Training

Interventions

Conventional Gait Training OTHER

onventional walking training group will be given 20 minutes of NMES, 20 minutes of weight transfer, stretching, mobilization, bobath exercises and 20 minutes of parallel bar walking exercises. Patients in both groups will be treated 3 days a week, 1 hour a day for 6 weeks.

Conventional Gait Group

Robotic Gait Training OTHER

The robot-assisted walking group will receive 20 minutes of NMES, 20 minutes of weight transfer, stretching,mobilization, bobath exercises and 20 minutes of robot-assisted walking exercises. Patients in both groups will be treated 3 days a week, 1 hour a day for 6 weeks

Robotic Gait Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a history of cerebrovascular accident at least 6 months ago;
• a score of at least 20 on the mini mental test;
• no botulinum toxin treatment for the last 3 months;
• a score of 2 or above on the Functional Ambulation Scale;
• a score of 3 or above on the Brunnstrom motor staging scale in terms of lower extremity recovery level

You may not qualify if:

• presence of concomitant neurologic, orthopedic, cardiovascular disease and acute comorbidities
• severe spasticity of lower extremity muscles, more than 2 on the Modified Ashworth Scale

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Güzin Kaya Aytutuldu

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Chang JJ, Tung WL, Wu WL, Su FC. Effect of bilateral reaching on affected arm motor control in stroke--with and without loading on unaffected arm. Disabil Rehabil. 2006 Dec 30;28(24):1507-16. doi: 10.1080/09638280600646060.

  PMID: 17178614 BACKGROUND

• Yoo DH, Kim SY. Effects of upper limb robot-assisted therapy in the rehabilitation of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):677-9. doi: 10.1589/jpts.27.677. Epub 2015 Mar 31.

  PMID: 25931706 BACKGROUND

• Lee KB, Lim SH, Kim YD, Yang BI, Kim KH, Lee KS, Kim EJ, Hwang BY. The contributions of balance to gait capacity and motor function in chronic stroke. J Phys Ther Sci. 2016 Jun;28(6):1686-90. doi: 10.1589/jpts.28.1686. Epub 2016 Jun 28.

  PMID: 27390395 BACKGROUND

• Hacmon RR, Krasovsky T, Lamontagne A, Levin MF. Deficits in intersegmental trunk coordination during walking are related to clinical balance and gait function in chronic stroke. J Neurol Phys Ther. 2012 Dec;36(4):173-81. doi: 10.1097/NPT.0b013e31827374c1.

  PMID: 23095903 BACKGROUND

• Sanchez-Sanchez ML, Ruescas-Nicolau MA, Carrasco JJ, Espi-Lopez GV, Perez-Alenda S. Cross-sectional study of quadriceps properties and postural stability in patients with chronic stroke and limited vs. non-limited community ambulation. Top Stroke Rehabil. 2019 Oct;26(7):503-510. doi: 10.1080/10749357.2019.1634360. Epub 2019 Jun 27.

  PMID: 31246150 BACKGROUND

• Shin J, An H, Yang S, Park C, Lee Y, You SJH. Comparative effects of passive and active mode robot-assisted gait training on brain and muscular activities in sub-acute and chronic stroke. NeuroRehabilitation. 2022;51(1):51-63. doi: 10.3233/NRE-210304.

  PMID: 35311717 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Güzin Kaya Aytutuldu

CONTACT

05366265884; guzinkaya14@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: December 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)