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

NCT ID: NCT05316896

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-11-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Internal perturbation

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.

Group Type: EXPERIMENTAL

Internal Perturbation

Intervention Type: 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.

Eksternal perturbation

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.

Group Type: EXPERIMENTAL

Eksternal Perturbation

Intervention Type: 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.

Interventions

Internal Perturbation

• 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.

Intervention Type: OTHER

Eksternal Perturbation

• 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Nagihan Bodur

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol University Sefakoy Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nagihan BODUR

Role: CONTACT

nagihanbdr@gmail.com

+905365034097

Facility Contacts

Nagihan Bodur

Role: primary

nagihanbdr@gmail.com

+905365034097

Other Identifiers

MedipolUni

Identifier Type: -

Identifier Source: org_study_id