NCT07792343

Brief Summary

This randomized controlled study aims to investigate the effects of perturbation-based balance training using pressure biofeedback on balance ability, hip function, and falls efficacy in patients after total hip arthroplasty (THA). Thirty participants who underwent THA will be randomly assigned to either a perturbation-based balance training group or a conventional balance training group. Both groups will receive intervention five times per week for 6 weeks in addition to conventional physical therapy. Outcome measures include Berg Balance Scale, Functional Reach Test, Falls Efficacy Scale, Harris Hip Score, Lower Extremity Functional Scale, and center of pressure (COP) parameters. The study is expected to provide clinical evidence for improving balance control and reducing fall risk in patients after THA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 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

October 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 24, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

pertubation balance training

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale (BBS)

    Functional balance assessed with the Berg Balance Scale, a 14-item performance-based scale scored from 0 to 56, with higher scores indicating better balance.

    Baseline and after 6 weeks of intervention

Secondary Outcomes (4)

  • Functional Reach Test (FRT)

    Baseline and after 6 weeks of intervention

  • Falls Efficacy Scale (FES)

    Baseline and after 6 weeks of intervention

  • Harris Hip Score (HHS)

    Baseline and after 6 weeks of intervention

  • Lower Extremity Functional Scale (LEFS)

    Baseline and after 6 weeks of intervention

Other Outcomes (10)

  • Mean COP velocity, eyes open (cm/s)

    Baseline and after 6 weeks of intervention

  • COP root mean square distance, eyes closed (cm)

    Baseline and after 6 weeks of intervention

  • COP 95% confidence ellipse area, eyes closed (cm^2)

    Baseline and after 6 weeks of intervention

  • +7 more other outcomes

Study Arms (2)

Pressure Biofeedback-Based Perturbation Balance Training Group

EXPERIMENTAL

Participants will receive perturbation-based balance training using pressure biofeedback in addition to conventional physical therapy. The intervention will be conducted for 15 minutes per session, five times per week, for six weeks.

Behavioral: pertubation based on balance training

Conventional Balance Training

ACTIVE COMPARATOR

Participants performed traditional balance training combined with conventional physical therapy. Training included static and dynamic balance exercises, weight shifting, postural control tasks, and functional reaching activities without pressure biofeedback. The intervention was conducted for 30 minutes per session, 5 sessions per week, for 6 weeks.

Behavioral: Traditional Balance Training

Interventions

Participants performed perturbation-based balance training using pressure biofeedback devices in addition to conventional physical therapy. During standing tasks, pressure biofeedback units were placed under both feet, and temporary instability was induced by adjusting air pressure to alter support surface stability. Participants performed progressive balance tasks including static standing, weight shifting, multidirectional reaching, and PNF-based reaching patterns. Training intensity and task difficulty were progressively increased according to participant performance. The intervention was conducted for 15 minutes per session, 5 sessions per week, for 6 weeks under therapist supervision.

Pressure Biofeedback-Based Perturbation Balance Training Group

Participants in the control group received traditional balance training without pressure biofeedback. The intervention included static and dynamic balance exercises, postural control training, weight-shifting tasks, and posture transition activities. The training tasks were performed in the same sequence and progression as the experimental group, but without perturbation induced by pressure biofeedback devices. Participants received training for 30 minutes per session, 5 times per week, for 6 weeks in addition to conventional physical therapy.

Conventional Balance Training

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent total hip arthroplasty (THA)
  • Postoperative period between 2 weeks and 6 months
  • Ability to understand and follow therapist instructions
  • Able to stand independently with or without an assistive device
  • Berg Balance Scale (BBS) score between 21 and 45
  • Receiving inpatient rehabilitation and physical therapy

You may not qualify if:

  • Severe cognitive impairment (K-MMSE \< 18)
  • Severe visual impairment or vestibular dysfunction
  • Any neurological or musculoskeletal disorder affecting balance other than THA
  • Unstable cardiovascular or medical conditions that could interfere with participation
  • Inability to safely participate in balance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu University

Gyeongsan-si, Gyeongsangbuk-do, 38453, South Korea

Location

Study Officials

  • Deok Hoon Jun

    Daegu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start

October 28, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations