Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation

NCT05316896 | Unknown

• 1 other identifier: MedipolUni
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a serious medical condition that causes the death of brain cells as a result of blockage of a blood vessel that feeds the brain (ischemic stroke) or bleeding in or around the brain (hemorrhagic stroke). People who have had a stroke have a higher risk of falling than people who have not had a stroke at the same age. Lack of balance control not only increases the risk of falling, but also leads to fear of falling and reduces the integration of people with stroke into society. The central nervous system uses two main postural strategies to maintain and restore balance when perturbed. These; are anticipatory and compensatory postural adjustments. Anticipatory postural adjustments control the position of the body's center of mass by activating the trunk and leg muscles prior to a forthcoming body perturbation, thus minimizing the risk of loosing equilibrium. Compensatory postural adjustment are initiated by sensory feedback signals and serve as a mechanism of restoration of the position of the center of mass after a perturbation has already occurred. In this study, the investigators aimed to determine which one is more effective, unlike previous studies that showed that internal and external perturbation exercises were effective when applied together. For this purpose, the researchers the planned to investigate and compare the effects on balance, performance, activity and participation in individuals to whom only internal perturbations were applied and only external perturbations were applied. The participants will be divided into 2 groups, as Group A and Group B, with 10 participants in each group, in a randomized controlled manner. Treatment Protocol: Conventional treatment was applied to participants included in both groups for 4 weeks, 5 days a week, 40-minute sessions. In addition to conventional treatment, 30 minutes of perturbation-based balance training was given to the participant in the study. Participants in Group A received internal perturbation training, and participants in Group B received external perturbation training.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Change from baseline in dynamic and static balance on the Berg Balance Scale at 4 weeks

  Berg balance scale is a valid and reliable test that measures both dynamic and static balance. It evaluates the body's ability to maintain position during 14 different activities in which the support surface decreases and the center of gravity changes, by observation. It is scored between 0-4 points, while at 0 the activity cannot be completed, at 4 it is completed independently. The total score is 56. If the score obtained at the end of the test is between 0-20, it is interpreted as poor balance skills, between 21-40 as acceptable balance and between 41-56 as advanced balance skills.

  baseline and 4 weeks

• Change from baseline in balance on the Timed Up and Go Test at 4 weeks

  For the timed up and go test, the patient gets up from the chair without arm support, walks 3 meters, returns and sits back in the chair. The total time it takes to complete the test is recorded in seconds using a stopwatch. The evaluation results are valid as they include maneuvers used in daily life. Individuals with independent balance and mobility skills complete the test in less than 10 seconds, individuals who complete it in more than 30 seconds are dependent on many activities and mobility skills in daily life.

  baseline and 4 weeks

• Change from baseline in balance 10-meter Walking Test at 4 weeks

  In this test, the person is asked to walk at his own normal pace in a pre-measured 10-meter area. The time starts when the person's foot is on the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters/second.

  baseline and 4 weeks

• Change from baseline in balance on the One Leg Standing Test at 4 weeks

  One foot is lifted so that it does not touch the other leg and the time is measured with a stopwatch. At first the eyes are open. When the eye open test is completed, the test is done with the eyes closed and it is expected that he can maintain his balance for 30 seconds. An imbalance is considered if the lifted leg touches the other leg, the foot touches the floor, bounces or bounces, or anything in the environment is touched for support.

  baseline and 4 weeks

Secondary Outcomes (7)

• Change from baseline in daily life activities on the Nottingham Health Profile at 4 weeks

  baseline and 4 weeks

• Change from baseline in ambulation ability on the Functional Ambulation Classification (FAS) at 4 weeks

  baseline and 4 weeks

• Motor development in stroke patients on the Brunnstrom Hemiplegia Recovery Staging at baseline

  baseline

• Assessment method for spasticity on the Modified Ashworth Scale at baseline

  baseline

• Change from baseline in level of disability on the Barthel Index at 4 weeks

  baseline and 4 weeks

Study Arms (2)

Internal perturbation

EXPERIMENTAL

The people included in this group did 6 internal perturbation exercises with 10 repetitions in each session. The patients performed a total of 60 perturbation exercises in one session. Perturbations were chosen according to the patient's tolerance, from easy to difficult. Treatment protocols of stroke individuals were determined according to their functional levels. 6 of the exercises given below were chosen according to the levels determined at the beginning of the study and were progressed by getting more difficult.

Other: Internal Perturbation

Eksternal perturbation

EXPERIMENTAL

The individuals included in this group performed 6 external perturbation exercises with 10 repetitions in each session. The patients performed a total of 60 perturbation exercises in one session. Perturbations were chosen according to the patient's tolerance, from easy to difficult. Treatment protocols of stroke individuals were determined according to their functional levels. 6 of the exercises given below were chosen according to the levels determined at the beginning of the study and were progressed by getting more difficult.

Other: Eksternal Perturbation

Interventions

Internal Perturbation OTHER

* Raising and lowering arms 90 degrees forward and sideways with eyes open and closed. * In tandem stance with eyes open and closed, arms are raised and lowered 90 degrees forward and to the side. * While standing on one leg with eyes open and closed, arms are raised and lowered 90 degrees forward and to the side. * Step forward and backward with right and left foot alternately * Take a step back and step back alternately with right and left foot * Put the right foot on the step and take it back, then do the same with the left foot and ask the patient to do it quickly. * First step on the step with the right foot and put the left foot next to it, then step down with the right foot and take the left foot with it, repeat the same with the left foot and ask the patient to do this. rapidly. * Normal gait, sideways gait, tandem gait, backward gait, raising and lowering the arms forward and sideways 90 degrees, respectively, during back-to-back tandem gait.

Internal perturbation

Eksternal Perturbation OTHER

* Front, side, and rear loading and release, pushing and pulling while standing with eyes open and closed * Front, side and rear loading and release, pushing and pulling while standing in tandem with eyes open and closed * Loading and releasing from the front, sides and back, pushing and pulling while turning the head left and right while standing * Front, side and rear loading and release, pushing and pulling while standing up and down with eyes open and closed * Front, side, and rear loading and release, pushing and pulling while standing on one leg with eyes open and closed * Holding the ball thrown by physiotherapist * Kicking a ball thrown by physiotherapist * Holding the ball thrown by the physiotherapist while standing in tandem, walking, walking sideways, walking in tandem, walking backwards.

Eksternal perturbation

Eligibility Criteria

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

You may qualify if:

• Unilateral stroke history
• Adults with chronic stroke (\>6 months poststroke)
• Ability to stand for at least 30 seconds without support

You may not qualify if:

• Those with Parkinson's disease, amputation, severe osteoporosis
• Those with uncontrolled diabetes, hypertension
• In addition to stroke, the presence of any problem that may adversely affect balance
• Areas below 24 in the mini mental state test

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University Sefakoy Hospital

Istanbul, 34515, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Nagihan BODUR

CONTACT

+905365034097; nagihanbdr@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: Physiotherapist

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 7, 2022
• Study Start: April 20, 2022
• Primary Completion: August 20, 2022
• Study Completion: November 20, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

TU (1)