NCT05173389

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

December 4, 2021

Last Update Submit

August 31, 2026

Conditions

Keywords

Stroke rehabilitationBalance trainingDistal controlPostural stabilityNeuroplasticityVirtual assessment tools

Outcome Measures

Primary Outcomes (1)

  • "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.

    Baseline and after 4 weeks of rehabilitation

Secondary Outcomes (5)

  • Berg Balance Scale (BBS)

    Baseline and after 4 weeks of rehabilitation

  • TechnoBody Balance Test

    Baseline and after 4 weeks of rehabilitation

  • Functional Reach Test (FRT)

    Baseline and after 4 weeks of rehabilitation

  • Trunk Impairment Scale (TIS)

    Baseline and after 4 weeks of rehabilitation

  • 5-Repetition Sit-to-Stand Test (SST)

    Baseline and after 4 weeks of rehabilitation

Other Outcomes (3)

  • "PostureScreen Mobile"

    Baseline and after 4 weeks of rehabilitation

  • Timed Up and Go Test (TUG)

    Baseline and after 4 weeks of rehabilitation

  • Functional Independence Measure (FIM)

    Baseline and after 4 weeks of rehabilitation

Study Arms (2)

Distal Balance Training (DBT) Group

EXPERIMENTAL

Distal (ankle-strategy) balance training using the Technobody Prokin system.

Device: TechnoBody intervention

Proximal Balance Training (PBT) Group

EXPERIMENTAL

Proximal (hip-strategy) balance training using the TheraTrainer Balo device.

Device: Thera-Trainer intervention

Interventions

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.

Distal Balance Training (DBT) Group

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.

Proximal Balance Training (PBT) Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erenköy Physical Therapy and Rehabilitation Hospital

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

Location

Study Officials

  • Naziye Şenyuva Ceyhan

    Istanbul University Cerrapasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective Paralel Group Comparison Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 4, 2021

First Posted

December 29, 2021

Study Start

August 1, 2019

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations