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Completed

NCT Number: NCT05173389

Distal Versus Proximal Balance Training in Chronic Stroke

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.

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Key information

Conditions

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erenköy Physical Therapy and Rehabilitation Hospital

Istanbul, Merdivenkoy-Kadıköy, 34732, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TechnoBody intervention

Device

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.

Thera-Trainer intervention

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.

Primary outcomes

  1. "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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. "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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Comparison of the Effects of Distal Versus Proximal Balance Training on Postural Stability and Functional Outcomes in Chronic Stroke: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2021
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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