Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling

NCT04228159 | Unknown

• 1 other identifier: fall prevention BT
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

One third of adults over 65 and 50% of adults above 80 years old fall at list once a year. In some cases, falls result in fractures, hospitalization, functional limitations, depression, morbidity and mortality. Strong evidence support exercise training programs for fall prevention, while several studies examined the effect of perturbation training on risk of fall. The aim of this study is to evaluate the effectiveness of a perturbation training program with unexpected perturbation using balance tutor on falls and injuries among elderly at risk of falling, compared to balance and strengthening exercise.

Conditions

Fall Prevention

Keywords

Accidental Falls, Frail Elderly, Physical Therapy Specialty

Outcome Measures

Primary Outcomes (2)

• rate of falls and fallers

  falls and fallers rates during 12-months following end of treatment

• hip fractures and hospitalizations rates due to falls

  hip fractures and hospitalizations rates due to falls during12-months following end of treatment

Secondary Outcomes (3)

• Mini-BESTest

  end of treatment-last visit in physical therapy clinic

• Activities-Specific Balance Confidence Scale (ABC scale)

  12 months after end of treatment

• Physical Activity Scale for the Elderly (PASE)

  12 months after end of treatment

Study Arms (2)

Perturbation training

EXPERIMENTAL

Session1 - baseline assessment (detailed above) Session2 - 13 - each session will begin with reassessment and documentation of balance tutor parameters for each participant as were calibrated at the end of previous session. After reassessment the training program will include: * Warm up - walking without perturbation. * Perturbation during standing position. * Perturbation during walking. * Perturbation during tandem position. * Perturbation with vestibular stimulation. * Rest according to patient needs The relative duration of each component, as well as intensity and frequency of perturbations, will be adjusted to each individual according to his ability, reassessment parameters and progression. Session14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.

Device: Balance Tutor Biofeedback Rehabilitation System

Balance and strengthening exercise

ACTIVE COMPARATOR

Session1 - baseline assessment (detailed above). Session2 - 13 - each session will include: * Warm up (free walking or cycling). * Static balance exercise - standing position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation. * Dynamic balance exercise - walking position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation. * Strengthening exercise - general strengthening, particularly for lower limb. * Cool down. Level of difficulty and duration of each component will be adjusted to each individual according to his ability and progression. Session14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.

Other: Balance and strengthening exercise

Interventions

Balance Tutor Biofeedback Rehabilitation System DEVICE

Balance Tutor system is a unique technology which allows for several postural control ability assessments as well as reactive response training in both standing and walking using controlled perturbation in simple task or multitask performance. Together with proactive training the system allows for optimal rehabilitation outcome and recovery

Perturbation training

Balance and strengthening exercise OTHER

exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance

Balance and strengthening exercise

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Clalit Health Services: lead
• MediTouch Ltd.: collaborator

Study Sites (3)

Clalit HealthCare services

Beersheba, Israel

RECRUITING

Clalit Healthcare Services

Holon, Israel

RECRUITING

Clalit HealthCare Services

Nazareth, Israel

RECRUITING

Study Officials

• Shlomit Yaron, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Shashua, PhD

CONTACT

972-50-8803223; Anatsh6@clalit.org.il

Igal Levran, MHA BPT

CONTACT

972-50-6262223; ilevran@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control trial. Older adults at moderate and high risk of falling will be recruited among Clalit patients referred to one of three physical therapy clinics, or other clinics nearby, neither by physician referral due to gait abnormality or following the physiotherapist diagnosis. Potential participants fulfilling the inclusion criteria and not meeting the exclusion criteria will sign informed consent and continue with baseline assessment. Those not wishing to participate will continue with routine care. Once the baseline assessment is completed, participants will be randomized into one of two intervention groups using computer random allocation software. Participants in both groups will attend physical therapy clinics twice a week for a total of 14 sessions. Each session will last 30 minutes. General information regarding fall prevention will be delivered to all participants using Clalit brochures and electronic prescriptions

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 14, 2020
• Study Start: November 25, 2019
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2022
• Last Updated: January 14, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)