The Effect of Robot-Assisted Gait Training in Stroke Patients

NCT04756570 | Completed

• 1 other identifier: Physical Med-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke has been defined by the World Health Organization as a condition with rapid onset and vascular origin, leading to a focal or global deterioration in brain functions lasting 1 day or longer. Stroke is an important health problem affecting a large part of the society with its high frequency and mortality. Post-stroke disability reduces the patient's quality of life and causes socioeconomic and social problems. Post-stroke hemiplegia often causes a decrease in the ambulatory ability of the patient. As a result, the patient's independence to move inside and outside the home is negatively affected. Gait is one of the most affected sensorimotor functions in stroke patients. Although the majority of patients strive to walk independently, they cannot reach a level of independent walking sufficient to perform activities of daily living (ADL). Current studies emphasize that the intensive early rehabilitation program is effective in treating patients with gait and movement disorders. Rehabilitation programs with a multidisciplinary approach are the most effective options that can be applied to increase a patient's functional status and post-stroke independence. Robotic-assisted walking devices are one of the current and effective methods used to regain ambulation.

Conditions

Stroke

Keywords

Rehabilitation; Robotic; Stroke

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  It is a scale that includes fourteen balance activities and scores between 0-4 by observing the patient's performance for each activity. This scale includes activities such as moving from a sitting position to a standing position, turning while standing, picking up objects while standing, rotating 360 degrees, standing on one foot. If the patient cannot do the activity, 0 points are given, and 4 points are given if the patient does the activity independently. Low scores indicate impaired balance. The highest total score is 56 and 0-20 points indicate an imbalance, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance.

  Six weeks

Secondary Outcomes (4)

• The Barthel Index

  Six weeks

• Stroke-Specific Quality of Life Scale

  Six weeks

• 6-min walk test

  Six weeks

• Modified Rankin Scale

  Six weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose Mini-Mental State Examination (MMSE) scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale (SSQOL) assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks

Other: Control

Robotic 1

ACTIVE COMPARATOR

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks

Other: Robotic Group 1

Robotic 2

ACTIVE COMPARATOR

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks

Other: Robotic Group 2

Interventions

Control OTHER

Individuals in this group will be randomly recruited from hospitalized stroke volunteers. Since these individuals receive routine rehabilitation 5 days a week, they will be evaluated at the beginning and end of 18 sessions over a total period of 6 weeks. Conventional physiotherapy will include normal joint movements, muscle strengthening exercises, balance and mobility exercises, and exercises to improve daily life activity.

Also known as: Conventional therapy

Control

Robotic Group 1 OTHER

Individuals in this group will receive one session of robotic rehabilitation in addition to conventional therapy each week

Robotic 1

Robotic Group 2 OTHER

Individuals in this group will receive two sessions of robotic rehabilitation in addition to conventional therapy each week

Robotic 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with stroke
• Willing to participate
• Modified Ashworth Scale Score lower than "3"
• Able to walk 10 meter independently

You may not qualify if:

• Secondary neurological diseases
• Cognitive problems

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14100, 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 Officials

• Mustafa Fatih Yaşar, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant will be evaluated by an another investigator who does not aware of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Three groups with one control group

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: March 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)