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Recruiting NCT06774833

Self-initiated Perturbation-based Training in Older Adults

No phase Interventional Healthy Subjects (HS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-initiated perturbation-based balance training, Conventional balance training.
Who it may be relevant to
Registry conditions: Healthy Subjects (HS). Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Self-initiated Perturbation-based Balance Training on the Postural Stability of Community-dwelling Older Adults With An Increased Risk of Falling: A Randomized Controlled Trial

Overview

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.

Detailed description

Participants will be randomly assigned to two groups receiving SePBT or control group. All participants will give their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenient sampling in the local community. After baseline assessment, both groups will go through two 30-minute training session over two weeks. Between-group differences in behavior will be examined before and after training to identify training-induced changes in postural stability. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.

Interventions

  • Behavioral Self-initiated perturbation-based balance training
    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.
  • Behavioral Conventional balance training
    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.

Primary outcome measures

  • Postural stability [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
Secondary outcome measures (12)
  • Generic balance ability [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Mobility [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention]
  • Number of real-life falls [Time frame: 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 [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Responsive postural adjustment upon tilting [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Dynamic balance [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Balance confidence [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Functional lower body strength [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Cognitive flexibility and executive function [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Number of laboratory falls [Time frame: Pre-intervention, 1 week after intervention and 4 months after intervention.]
  • Cognitive impairment [Time frame: Pre-intervention.]
  • Depressive symptoms [Time frame: Pre-intervention.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Uncorrected vision or hearing impairment
  • Osteoporosis
  • Have a historyof hip or knee replacement
  • Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety
  • Participating or planning to participate in another fall prevention program.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT06774833 · HSEARS20240505001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗