Chronic StrokeNCT05173389
Distal Versus Proximal Balance Training in Chronic Stroke
A study testing TechnoBody intervention and Thera-Trainer intervention in people with Chronic Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- TechnoBody intervention and Thera-Trainer intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erenköy Physical Therapy and Rehabilitation Hospital
Istanbul, Merdivenkoy-Kadıköy, 34732
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Stroke
- Being tested
- TechnoBody intervention, Thera-Trainer intervention
- Keywords
- Stroke rehabilitation, Balance training, Distal control, Postural stability, Neuroplasticity, Virtual assessment tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TechnoBody interventionDevice
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 interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Distal Balance Training (DBT) Group | Experimental | Distal (ankle-strategy) balance training using the Technobody Prokin system. Receives: Device: TechnoBody intervention |
| Proximal Balance Training (PBT) Group | Experimental | Proximal (hip-strategy) balance training using the TheraTrainer Balo device. Receives: Device: Thera-Trainer intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Single Leg Stance Test (SLST)"
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.
Measured: Baseline and after 4 weeks of rehabilitation
Secondary outcomes (5)
Berg Balance Scale (BBS)
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.
Measured: Baseline and after 4 weeks of rehabilitation
TechnoBody Balance Test
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.
Measured: Baseline and after 4 weeks of rehabilitation
Functional Reach Test (FRT)
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.
Measured: Baseline and after 4 weeks of rehabilitation
Trunk Impairment Scale (TIS)
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.
Measured: Baseline and after 4 weeks of rehabilitation
5-Repetition Sit-to-Stand Test (SST)
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.
Measured: Baseline and after 4 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Aug 2019
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Paralel Group Comparison Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naziye Ş CEYHAN, PhD, Istanbul University - Cerrahpasa
- Investigators
- Naziye Şenyuva Ceyhan, Principal investigator, Istanbul University Cerrapasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173389
- Sponsor's protocol ID
- ıstanbulıucnazıye
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Distal Versus Proximal Balance Training on Postural Stability and Functional Outcomes in Chronic Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05173389
- Acronym / sponsor ID
- ıstanbulıucnazıye
- Conditions
- Chronic Stroke
- Keywords
- Stroke rehabilitation, Balance training, Distal control, Postural stability, Neuroplasticity, Virtual assessment tools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Paralel Group Comparison Study
| Arm | Type | Receives |
|---|---|---|
| Distal Balance Training (DBT) Group | Experimental | Device: TechnoBody interventionDistal (ankle-strategy) balance training using the Technobody Prokin system. |
| Proximal Balance Training (PBT) Group | Experimental | Device: Thera-Trainer interventionProximal (hip-strategy) balance training using the TheraTrainer Balo device. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TechnoBody interventionParticipants 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. | Device | Distal Balance Training (DBT) Group |
| Thera-Trainer interventionParticipants 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. | Device | Proximal Balance Training (PBT) Group |
Primary outcome
"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.
5 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline and after 4 weeks of rehabilitation
TechnoBody Balance Test
Time frame: Baseline and after 4 weeks of rehabilitation
Functional Reach Test (FRT)
Time frame: Baseline and after 4 weeks of rehabilitation
Trunk Impairment Scale (TIS)
Time frame: Baseline and after 4 weeks of rehabilitation
5-Repetition Sit-to-Stand Test (SST)
Time frame: Baseline and after 4 weeks of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naziye Şenyuva Ceyhan principal investigator
Istanbul University Cerrapasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TechnoBody intervention and Thera-Trainer intervention in people with Chronic Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Single Leg Stance Test (SLST)" (time frame: Baseline and after 4 weeks of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.