Cerebrovascular DisordersNCT02031757
Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments
A study testing perturbation training and balance exercises in people with Cerebrovascular Disorders and Peripheral Nervous System Diseases, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease, injury and surgery. One of the consequences of such deficit is an increased risk of fall and injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cerebrovascular Disorders, Peripheral Nervous System Diseases, Musculoskeletal Diseases
- What is being tested?
- perturbation training and balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory capability of over 2 in Functional Ambulation Classification .
- No less then 4 weeks following surgery.
- preserved mental capacity.
Who cannot join
- less then 4 weeks following surgery or injury.
- Symptomatic orthostatic hypotension, respiratory or cardiovascular, disorders that may interfere with participation in the perturbation program.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization,
Jerusalem
Arik Tzukert,, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg,, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: The Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments.
Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease, injury and surgery. One of the consequences of such deficit is an increased risk of fall and injury. A gait training regime that incorporates controlled perturbation has been found to reduce falls in elderly population but the effectiveness of such training has yet to be studied.
The aim of this study is to evaluate the effectiveness of specific controlled dynamic perturbation training, during gait, on gait rehabilitation, fear of falling and falling with gait impaired individuals. Perturbation will be performed using a specifically designed system that provides small, controlled and unpredictable perturbations during treadmill walking.
Read the detailed description
A total of 100 adults with gait dysfunction will be enrolled, evaluated and trained. They will be randomly assigned to two groups: perturbation training group and balance exercises group. Both groups will receive standard physiotherapy treatments. No gender based differences are expected so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 12 occasions over a period of 10-12 weeks (15 minutes, 2-3 times/week) in addition to standard care physiotherapy. Gait, balance function and fear of falling will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit of training.
- Conditions
- Cerebrovascular Disorders, Peripheral Nervous System Diseases, Musculoskeletal Diseases, Joint Diseases
- Being tested
- perturbation training, balance exercises
- Keywords
- Balance control, Aging, Balance reactions, Perturbation
- Medical subject headings
- Cerebrovascular Disorders, Peripheral Nervous System Diseases, Musculoskeletal Diseases, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perturbation trainingOther
training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.
balance exercisesOther
specific exercises regularly used in rehabilitation aiming to improve balance
| Study group | Role | What they receive |
|---|---|---|
| perturbation training | Experimental | Standard physiotherapy augmented with perturbation training (BaMPer system). Receives: Other: perturbation training |
| balance exercise | Active comparator | standard physiotherapy augmented with balance exercises. Receives: Other: balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
short Falls Efficacy Scale International (FES-I)
a short, easy to administer tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity
Measured: up to 6 months
Secondary outcomes (2)
Berg Balance Scale
The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks
Measured: UP TO 6 MONTHS
BalanceMaster LIMITS OF STABILITY (LOS) test
The LOS quantifies the maximum distance a person can intentionally displace their Center of Gravity without losing balance, stepping, or reaching for assistance.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031757
- Sponsor's protocol ID
- GaitPert-HMO-CTIL
- Status last verified
- Oct 2013
- First submitted
- 8 Jan 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments.
- ClinicalTrials.gov ID
- NCT02031757
- Acronym / sponsor ID
- GaitPert-HMO-CTIL
- Conditions
- Cerebrovascular Disorders, Peripheral Nervous System Diseases, Musculoskeletal Diseases, Joint Diseases
- Keywords
- Balance control, Aging, Balance reactions, Perturbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Jan 2014 (estimated)
- 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.
Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease, injury and surgery. One of the consequences of such deficit is an increased risk of fall and injury. A gait training regime that incorporates controlled perturbation has been found to reduce falls in elderly population but the effectiveness of such training has yet to be studied.
The aim of this study is to evaluate the effectiveness of specific controlled dynamic perturbation training, during gait, on gait rehabilitation, fear of falling and falling with gait impaired individuals. Perturbation will be performed using a specifically designed system that provides small, controlled and unpredictable perturbations during treadmill walking.
Detailed description
A total of 100 adults with gait dysfunction will be enrolled, evaluated and trained. They will be randomly assigned to two groups: perturbation training group and balance exercises group. Both groups will receive standard physiotherapy treatments. No gender based differences are expected so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 12 occasions over a period of 10-12 weeks (15 minutes, 2-3 times/week) in addition to standard care physiotherapy. Gait, balance function and fear of falling will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perturbation training | Experimental | Other: perturbation trainingStandard physiotherapy augmented with perturbation training (BaMPer system). |
| balance exercise | Active comparator | Other: balance exercisesstandard physiotherapy augmented with balance exercises. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory capability of over 2 in Functional Ambulation Classification .
- No less then 4 weeks following surgery.
- preserved mental capacity.
Key exclusion criteria (2 listed)
- less then 4 weeks following surgery or injury.
- Symptomatic orthostatic hypotension, respiratory or cardiovascular, disorders that may interfere with participation in the perturbation program.
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 |
|---|---|---|
| perturbation trainingtraining utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking. | Other | perturbation training |
| balance exercisesspecific exercises regularly used in rehabilitation aiming to improve balance | Other | balance exercise |
Primary outcome
short Falls Efficacy Scale International (FES-I)
Time frame: up to 6 months
a short, easy to administer tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity
2 secondary outcomes
Berg Balance Scale
Time frame: UP TO 6 MONTHS
BalanceMaster LIMITS OF STABILITY (LOS) test
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perturbation training and balance exercises in people with Cerebrovascular Disorders and Peripheral Nervous System Diseases, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hadas Lemberg, PHD (97226776095, LHADAS@HADASSAH.ORG.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short Falls Efficacy Scale International (FES-I) (time frame: up to 6 months). 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 5 Apr 2016.