- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173389
Distal Versus Proximal Balance Training in Chronic Stroke
Comparison of the Effects of Distal Versus Proximal Balance Training on Postural Stability and Functional Outcomes in Chronic Stroke: a Randomized Controlled Trial
Study will include two different intervention groups. Both groups will receive a standardized 50-minute multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training. In addition, both groups will receive 15 minutes of technology-assisted balance training, 5 days per week for 4 weeks.
Group 1 will receive distal (ankle-strategy) balance training (DBT) using the Technobody Prokin system, including interactive "Game Pong" tasks with controlled anteroposterior and mediolateral platform displacement.
Group 2 will receive proximal (hip-strategy) balance training (PBT) using the TheraTrainer Balo device.
Study Aim: To investigate and compare the effects of technology-assisted distal (ankle-strategy) versus proximal (hip-strategy) balance training, each added to a standardized multimodal rehabilitation program, on balance, posture and functional outcomes in individuals with chronic stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, participant- and assessor-blinded, two-group parallel randomized controlled trial included 46 participants aged 65-85 years with chronic stroke. Participants were randomly assigned in a 1:1 ratio to distal balance training (DBT) or proximal balance training (PBT), with 23 participants allocated to each group.
All participants received a standardized 50-minute multimodal rehabilitation program consisting of 30 minutes of Bobath-based therapeutic exercises, 10 minutes of neuromuscular electrical stimulation (NMES), and 10 minutes of bicycle ergometer training. In addition, participants received 15 minutes of technology-assisted balance training, 5 days per week for 4 weeks.
Participants in the DBT group received ankle-strategy-based balance training using the Technobody Prokin system. Training included interactive "Game Pong" tasks requiring controlled anteroposterior and mediolateral platform displacement. Participants in the PBT group received hip-strategy-based balance training using the TheraTrainer Balo device, which provided visual feedback during multidirectional trunk and pelvic control tasks.
Functional outcomes were assessed using the Timed Up and Go Test (TUG), 5-Repetition Sit-to-Stand Test (SST), and Functional Independence Measure (FIM). Balance was assessed using the Berg Balance Scale (BBS), Functional Reach Test (FRT), Trunk Impairment Scale (TIS), and Single-Leg Stance Test (SLST). Postural sway was assessed using the Technobody force platform, and postural alignment was assessed using the PostureScreen Mobile application. Cognitive status was assessed using the Standardized Mini-Mental Test (SMMT), which was administered once before treatment. All other outcome assessments were performed at baseline and after 4 weeks of rehabilitation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merdivenkoy-Kadıköy
-
Istanbul, Merdivenkoy-Kadıköy, Turkey (Türkiye), 34732
- Erenköy Physical Therapy and Rehabilitation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
nclusion Criteria:
Hemiparesis secondary to a prior stroke At least 6 months post-stroke Standardized Mini-Mental Test (SMMT) score between 18 and 23 Absence of visual impairment Ability to walk independently or with an assistive device Age between 65 and 85 years
Exclusion Criteria:
Contractures in joints of the hemiparetic extremity Peripheral nerve lesions or lower motor neuron disease Other neurological conditions such as ataxia, dyskinesia, or dystonia Uncontrolled hypertension Cardiac instability Any condition that could pose a risk during physical rehabilitation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Distal Balance Training (DBT) Group
Distal (ankle-strategy) balance training using the Technobody Prokin system.
|
Participants will receive distal (ankle-strategy) balance training using the Technobody Prokin system for 15 minutes per session, 5 days per week for 4 weeks.
In addition, participants will receive the standardized multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training.
|
|
Experimental: Proximal Balance Training (PBT) Group
Proximal (hip-strategy) balance training using the TheraTrainer Balo device.
|
Participants will receive proximal (hip-strategy) balance training using the TheraTrainer Balo device for 15 minutes per session, 5 days per week for 4 weeks.
In addition, participants will receive the standardized multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Single Leg Stance Test (SLST)"
Time Frame: Baseline and after 4 weeks of rehabilitation
|
For the test, volunteers were asked to lift one foot without touching the support leg, look steadily across, and maintain their balance for 30 seconds.
The time they focused on the paretic limb for hemiparetic individuals and the time they focused on the dominant limbs for healthy individuals were recorded.
|
Baseline and after 4 weeks of rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale (BBS)
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The Berg Balance Scale (BBS) was used to assess functional balance.
The scale consists of 14 items assessing balance during functional tasks.
Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 56.
Higher scores indicate better balance performance.
|
Baseline and after 4 weeks of rehabilitation
|
|
TechnoBody Balance Test
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The TechnoBody balance platform was used to assess postural balance.
The system measures center-of-pressure displacement over time.
Parameters including anteroposterior and mediolateral displacement, sway area, oscillation velocity, and total displacement distance were evaluated.
|
Baseline and after 4 weeks of rehabilitation
|
|
Functional Reach Test (FRT)
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The Functional Reach Test (FRT) was used to assess dynamic balance.
Functional reach distance was measured in centimeters.
Distances of ≥25 cm indicate good balance, 16-24 cm indicate moderate impairment, and ≤15 cm indicate a high risk of instability.
|
Baseline and after 4 weeks of rehabilitation
|
|
Trunk Impairment Scale (TIS)
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The Trunk Impairment Scale (TIS) was used to assess trunk control in participants with stroke.
The total score ranges from 0 to 23, with higher scores indicating better trunk control.
|
Baseline and after 4 weeks of rehabilitation
|
|
5-Repetition Sit-to-Stand Test (SST)
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The 5-Repetition Sit-to-Stand Test (SST) was used to assess functional lower-extremity performance.
Participants were instructed to stand up from and sit down on a chair five times as quickly as possible.
The time required to complete five repetitions was recorded in seconds.
A shorter completion time indicates better functional performance.
|
Baseline and after 4 weeks of rehabilitation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"PostureScreen Mobile"
Time Frame: Baseline and after 4 weeks of rehabilitation
|
Patients photography with apple telephone and, Pictures of subjects were taken in three standing positions.
Two raters independently digitized the static standing posture image twice.
The app calculated posture variables, including sagittal and coronal plane translations and angulations.
|
Baseline and after 4 weeks of rehabilitation
|
|
Timed Up and Go Test (TUG)
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The Timed Up and Go Test (TUG) was used to assess functional mobility and balance.
Participants were instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.
The test was repeated three times, and performance time was measured with a stopwatch and recorded in seconds.
A shorter completion time indicates better functional mobility.
|
Baseline and after 4 weeks of rehabilitation
|
|
Functional Independence Measure (FIM)
Time Frame: Baseline and after 4 weeks of rehabilitation
|
The Functional Independence Measure (FIM) was used to assess functional independence in activities of daily living.
It consists of 18 items, including 13 motor and 5 cognitive items.
Each item is scored from 1 to 7, resulting in a total score ranging from 18 to 126.
Higher scores indicate greater functional independence.
|
Baseline and after 4 weeks of rehabilitation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naziye Şenyuva Ceyhan, Istanbul University Cerrapasa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ıstanbulıucnazıye
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.