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

NCT ID: NCT04228159

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2022-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Fall Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Perturbation training

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.

Group Type EXPERIMENTAL

Balance Tutor Biofeedback Rehabilitation System

Intervention Type 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

Balance and strengthening exercise

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.

Group Type ACTIVE_COMPARATOR

Balance and strengthening exercise

Intervention Type OTHER

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

Interventions

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Balance Tutor Biofeedback Rehabilitation System

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

Intervention Type DEVICE

Balance and strengthening exercise

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MediTouch Ltd.

UNKNOWN

Sponsor Role collaborator

Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shlomit Yaron, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Locations

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Clalit HealthCare services

Beersheba, , Israel

Site Status RECRUITING

Clalit Healthcare Services

Holon, , Israel

Site Status RECRUITING

Clalit HealthCare Services

Nazareth, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Anat Shashua, PhD

Role: CONTACT

972-50-8803223

Igal Levran, MHA BPT

Role: CONTACT

972-50-6262223

Facility Contacts

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Anat Shashua, PhD

Role: primary

972508803223

Igal Levran, MHA BPT

Role: backup

972506262223

Anat Shashua, PhD

Role: primary

972508803223

Igal Levran, MHA BPT

Role: backup

972506262223

Anat H Shashua, PhD

Role: primary

972508803223 ext. 972508803223

Igal H Levran, MHA BPT

Role: backup

972506262223 ext. 972508803223

Other Identifiers

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fall prevention BT

Identifier Type: -

Identifier Source: org_study_id

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