Clinical trial NCT06774833: Self-initiated Perturbation-based Training in Older Adults
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects (HS)
Keywords: Perturbation
Step training
Falls
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to SePBT or conventional balance training group.
Primary purpose: SUPPORTIVE_CARE

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.

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.

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
* 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

Primary outcomes:
measure: Postural stability
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
Secondary outcomes:
measure: Generic balance ability
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Mobility
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention
measure: Number of real-life falls
timeFrame: 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.
measure: Responsive postural adjustment upon translation
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Responsive postural adjustment upon tilting
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Dynamic balance
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Balance confidence
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Functional lower body strength
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Cognitive flexibility and executive function
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Number of laboratory falls
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Cognitive impairment
timeFrame: Pre-intervention.
measure: Depressive symptoms
timeFrame: Pre-intervention.
measure: Personality traits
timeFrame: Pre-intervention.
measure: Generic preference-based quality-of-life
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Muscle activations
timeFrame: Pre-intervention, 1 week after intervention and 4 months after intervention.
measure: Physical activity
timeFrame: Pre-intervention, and 4 months after intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: