NCT06774833

Brief Summary

This is a single-blinded study. Participants will be randomly assigned to self-initiated perturbation-based balance training (SePBT) group or control (conventional balance training) group. Kinematic and Kinetic changes following SePBT group compared to control will be investigated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress70%
Nov 2024Dec 2026

Study Start

First participant enrolled

November 6, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

January 9, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

PerturbationStep trainingFalls

Outcome Measures

Primary Outcomes (1)

  • Postural stability

    Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute center of mass (CoM) position in an anteroposterior direction relative to the closest edge of the Base of Support (BoS) normalized by foot length. The absolute CoM position and BoS position will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts.

    Pre-intervention, 1 week after intervention and 4 months after intervention.

Secondary Outcomes (16)

  • Generic balance ability

    Pre-intervention, 1 week after intervention and 4 months after intervention.

  • Mobility

    Pre-intervention, 1 week after intervention and 4 months after intervention

  • Number of real-life falls

    1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.

  • Responsive postural adjustment upon translation

    Pre-intervention, 1 week after intervention and 4 months after intervention.

  • Responsive postural adjustment upon tilting

    Pre-intervention, 1 week after intervention and 4 months after intervention.

  • +11 more secondary outcomes

Study Arms (2)

Self-initiated perturbation-based balance training group

EXPERIMENTAL

This group will receive two sessions of self-initiated perturbation-based balance training.

Behavioral: Self-initiated perturbation-based balance training

Conventional balance training group

ACTIVE COMPARATOR

This group will receive two sessions of balance and strength training.

Behavioral: Conventional balance training

Interventions

This group will receive two 30-minute training sessions over two weeks, with one session per week. Participants will be required to recover their balance upon self-initiated perturbation.

Self-initiated perturbation-based balance training group

This group will receive two 30-minute training sessions over two weeks, with one session per week. Participants will be instructed to perform balance and strength training. The same training duration and format will be used as the Self-initiated perturbation-based balance training group.

Conventional balance training group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling adults aged 60 years old or older
  • Able to communicate effectively in Cantonese or Mandarin
  • Able to walk independently on level ground for at least 30 minutes
  • Abbreviated Mental Test (Hong Kong version) scores≄6
  • Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing.

You may not qualify if:

  • Uncorrected vision or hearing impairment
  • Osteoporosis
  • Hip or knee replacement within the last year
  • Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to SePBT or conventional balance training group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 14, 2025

Study Start

November 6, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations