Fall PreventionNCT04228159
Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling
A study testing Balance Tutor Biofeedback Rehabilitation System and Balance and strengthening exercise in people with Fall Prevention, run by Clalit Health Services at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Fall Prevention
- What is being tested?
- Balance Tutor Biofeedback Rehabilitation System and Balance and strengthening exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesIsrael
- Study dates
- 25 Nov 2019to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Inclusion Criteria:at least one fall during the last 12 months; age 65-85; mini-mental state examination score 24 and above allowing cognitive ability to understand simple instructions ; Time Up and Go (TUG), assessing balance, walking ability and fall risk, scored 13 and above ; ability to read Hebrew or Arabic; and the ability to walk independently 10 meters.
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Exclusion Criteria:progressive neurological conditions (Parkinson, Multiple sclerosis, CVA); severe orthopedic conditions including lower limb or spine fractures and surgeries in the past 12 months prior to baseline; blindness; Arrhythmia; uncontrolled chronic disease (i.e., hypertension, diabetes, ischemic heart disease); diagnosed severe osteoporosis with a history of fracture during the past 3 years prior to baseline; active cancer during the past three years prior to baseline; lack of availability in the coming two months for completing the treatment protocol
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Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Clalit HealthCare services
Beersheba
Anat Shashua, PhD, 972508803223, Anatsh6@clalit.org.il
Igal Levran, MHA BPT, 972506262223, ilevran@clalit.org.il
- Recruiting
Clalit Healthcare Services
Holon
Anat Shashua, PhD, 972508803223, Anatsh6@clalit.org.il
Igal Levran, MHA BPT, 972506262223, ilevran@clalit.org.il
- Recruiting
Clalit HealthCare Services
Nazareth
Anat H Shashua, PhD, 972508803223 ext. 972508803223, Anatsh6@clalit.org.il
Igal H Levran, MHA BPT, 972506262223 ext. 972508803223, ilevran@clalit.org.il
About this study
Official title: The Effectiveness of Perturbation Training With Balance Tutor, Compared to Balance and Strengthening Exercise, on Falls Rate Among Elderly at Risk of Falling
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
- Being tested
- Balance Tutor Biofeedback Rehabilitation System, Balance and strengthening exercise
- Keywords
- Accidental Falls, Frail Elderly, Physical Therapy Specialty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Tutor Biofeedback Rehabilitation SystemDevice
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 exerciseOther
exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Balance and strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of falls and fallers
Measured: falls and fallers rates during 12-months following end of treatment
hip fractures and hospitalizations rates due to falls
Measured: hip fractures and hospitalizations rates due to falls during12-months following end of treatment
Secondary outcomes (3)
Mini-BESTest
Balance assessment according to Balance Evaluation Systems Test. The Mini-BESTest is a 14 item test scored on a 3-level ordinal scale. The total score is 28 while a lower score indicates severe balance impairment
Measured: end of treatment-last visit in physical therapy clinic
Activities-Specific Balance Confidence Scale (ABC scale)
The ABC scale is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Items are rated on a rating scale that ranges from 0-100; 0 represents "no confidence" and 10 represents "complete confidence".
Measured: 12 months after end of treatment
Physical Activity Scale for the Elderly (PASE)
The PASE measures the level of self-reported physical activity in individuals aged 65 years or older and is comprised of items regarding occupational, household, and leisure activities during the previous 7-days period
Measured: 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start25 Nov 2019
- Primary completion25 May 2021 (estimated)
- Study completion25 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- MediTouch Ltd.
- Responsible party
- Sponsor
- Investigators
- Shlomit Yaron, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228159
- Sponsor's protocol ID
- fall prevention BT
- Status last verified
- Dec 2019
- First submitted
- 13 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Perturbation Training With Balance Tutor, Compared to Balance and Strengthening Exercise, on Falls Rate Among Elderly at Risk of Falling
- ClinicalTrials.gov ID
- NCT04228159
- Acronym / sponsor ID
- fall prevention BT
- Conditions
- Fall Prevention
- Keywords
- Accidental Falls, Frail Elderly, Physical Therapy Specialty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- MediTouch Ltd.
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 25 May 2021 (estimated)
- Study completion
- 25 May 2022 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Perturbation training | Experimental | Device: Balance Tutor Biofeedback Rehabilitation SystemSession1 - 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. |
| Balance and strengthening exercise | Active comparator | Other: Balance and strengthening exerciseSession1 - 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance Tutor Biofeedback Rehabilitation SystemBalance 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 | Device | Perturbation training |
| Balance and strengthening exerciseexercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance | Other | Balance and strengthening exercise |
Primary outcome
rate of falls and fallers
Time frame: falls and fallers rates during 12-months following end of treatment
hip fractures and hospitalizations rates due to falls
Time frame: hip fractures and hospitalizations rates due to falls during12-months following end of treatment
3 secondary outcomes
Mini-BESTest
Time frame: end of treatment-last visit in physical therapy clinic
Activities-Specific Balance Confidence Scale (ABC scale)
Time frame: 12 months after end of treatment
Physical Activity Scale for the Elderly (PASE)
Time frame: 12 months after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Yaron, MD principal investigator
Clalit Health Services
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Tutor Biofeedback Rehabilitation System and Balance and strengthening exercise in people with Fall Prevention, run by Clalit Health Services at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Shashua, PhD (972-50-8803223, Anatsh6@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of falls and fallers (time frame: falls and fallers rates during 12-months following end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.