Clinical trial NCT05316896: Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation
Official title: Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in dynamic and static balance on the Berg Balance Scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in balance on the Timed Up and Go Test at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in balance 10-meter Walking Test at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in balance on the One Leg Standing Test at 4 weeks
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in daily life activities on the Nottingham Health Profile at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in ambulation ability on the Functional Ambulation Classification (FAS) at 4 weeks
timeFrame: baseline and 4 weeks
measure: Motor development in stroke patients on the Brunnstrom Hemiplegia Recovery Staging at baseline
timeFrame: baseline
measure: Assessment method for spasticity on the Modified Ashworth Scale at baseline
timeFrame: baseline
measure: Change from baseline in level of disability on the Barthel Index at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in quality of life on the Stroke Impact Scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in balance on the 4-Step Climbing Test at 4 weeks
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Sefakoy Hospital
Study officials:
References: