Interactive Posturographic Balance Training Added to Conventional Rehabilitation in Chronic Stroke

NCT07448948 | Completed

• 1 other identifier: CRS-TETRAX-2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke frequently leads to long-term balance impairments, increased fall risk, and reduced independence in daily activities. In chronic stroke patients, deficits in sensory integration and postural control may persist despite conventional rehabilitation programs. Additional targeted balance interventions may enhance recovery by improving multisensory processing and motor control. This study investigates whether adding biofeedback-based interactive posturographic balance training to conventional rehabilitation improves balance performance, fall risk, functional independence, and psychological well-being in individuals with chronic stroke. Participants were randomly assigned to receive either conventional rehabilitation alone or conventional rehabilitation combined with interactive balance training for eight weeks. Outcomes were assessed using validated clinical scales measuring balance, fall risk, daily functioning, and emotional status.

Conditions

Stroke; Postural Balance

Keywords

Chronic stroke; Balance training; Posturography; Biofeedback; Berg Balance Scale; Fall risk

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  The Berg Balance Scale is a 14-item clinical measure of balance performance scored from 0 to 56, with higher scores indicating better balance.

  Baseline and 8 weeks

Secondary Outcomes (3)

• Change in Barthel Index score from baseline to 8 weeks

  Baseline and 8 weeks

• Change in Fall Risk Index from baseline to 8 weeks

  Baseline and 8 weeks

• Change in Hospital Anxiety and Depression Scale (HADS) total score from baseline to 8 weeks

  Baseline and 8 weeks

Study Arms (2)

Interactive Posturographic Balance Training + Conventional Rehabilitation

EXPERIMENTAL

Participants received conventional rehabilitation (45 minutes per session, 5 sessions per week) combined with biofeedback-based interactive posturographic balance training (25 minutes per session) for 8 weeks. The balance training was conducted using a multisensory posturographic system providing real-time visual feedback under varying sensory conditions. The conventional rehabilitation program included neurophysiological facilitation techniques, range of motion exercises, strengthening exercises, postural control training, weight-shifting exercises, and gait training.

Device: Biofeedback-Based Interactive Posturographic Balance Training

Conventional Rehabilitation

ACTIVE COMPARATOR

Participants received conventional rehabilitation only (45 minutes per session, 5 sessions per week) for 8 weeks. The program consisted of neurophysiological facilitation techniques, range of motion exercises, strengthening exercises, postural control training, weight-shifting exercises, and gait training.

Behavioral: Conventional Rehabilitation Program

Interventions

Biofeedback-Based Interactive Posturographic Balance Training DEVICE

Intervention Description (Experimental Arm) Participants received biofeedback-based interactive posturographic balance training using a multisensory platform that provides real-time visual feedback based on vertical pressure fluctuations detected from four force plates under the heels and forefeet. The system systematically challenges postural control under different sensory conditions, including eyes open, eyes closed, unstable surface, and head-position variations. Training sessions lasted 25 minutes, five days per week, for eight weeks and were conducted in addition to a standardized conventional rehabilitation program.

Interactive Posturographic Balance Training + Conventional Rehabilitation

Conventional Rehabilitation Program BEHAVIORAL

Participants received a standardized conventional rehabilitation program consisting of neurophysiological facilitation techniques, range of motion exercises, muscle strengthening exercises, postural control training, weight-shifting exercises, and gait training. Sessions lasted 45 minutes per day, five days per week, for eight weeks.

Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6 months had elapsed since stroke onset
• They were ambulatory prior to stroke
• They were able to stand independently for at least 2 minutes
• Mini-Mental State Examination (MMSE) score ≥22

You may not qualify if:

• Medical conditions contraindicating participation in an exercise program
• Additional disorders affecting balance assessment (vertebrobasilar or peripheral vestibular insufficiency, significant visual impairment, neglect, cognitive impairment, major lower extremity contracture, neuromuscular disease, other neurological pathology, impaired joint position sense)
• Previous history of stroke
• Cerebellar involvement (dysmetria, dysdiadochokinesia, ataxia)

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Istanbul, Turkey

Istanbul, Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was blinded to group allocation throughout the study. Participants and treating therapists were not blinded due to the nature of the intervention. Participants were instructed not to disclose their group assignment during outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. One group received conventional rehabilitation combined with biofeedback-based interactive posturographic balance training, while the control group received conventional rehabilitation alone. Both groups underwent intervention for eight weeks without crossover between groups.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: February 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)