Old AdultsBalancINGNCT04455607
Perturbation Training to Improve Balance Recovery of Old Adults
A study testing perturbation training in people with Old Adults, run by Soroka University Medical Center at 3 sites in Israel.
Trial summary
Falls are major contributors for immobility and independency. Most falls in older adults occur during walking after a sudden unexpected loss of balance. It was well-established that balance can be improved by performance of a training program that provides perturbation (unexpected perturbations of balance). Read more about this study
- Who is it for?
- Ages 70 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Adults
- What is being tested?
- perturbation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesIsrael
- Study dates
- 1 Oct 2017to 31 Dec 2021
- 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 70 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 years and older (with the young age of 20-40)
- able to walk independently (without utilities treadmill or stick);
- Be asked to invent a medical certificate which allows participation in exercise that requires walking twice a week.
Who cannot join
- suffering from ischaemic heart disease which limits exercise and COPD and blood pressure is not controlled;
- not suffering serious vision problems;
- does not suffer from this problem: (a score of 24 or higher on MOCA);
- a year after analyzing the type of hip replacement or knee or broken extremities;
- Does not suffer any neurological diseases or stroke.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Ben-guion University of the Negev,
Beersheba, 84105
Soroka Medical Center
Beersheba, 84105
SorokaUMC
Beersheba, 84105
About this study
Official title: The Influence of a Perturbation Training on Balance Recovery of Old Adults - a Randomized Controlled Trial
Falls are major contributors for immobility and independency. Most falls in older adults occur during walking after a sudden unexpected loss of balance. It was well-established that balance can be improved by performance of a training program that provides perturbation (unexpected perturbations of balance). The main aim of the current study is to investigate the effects of two perturbation-training methods: 1) random perturbation training; vs. 2) block (non-random) perturbation training. We also aim to explore brain area's (as measured by MRI) that are related to balance function in older adults.
We hypothesize that response to an unexpected loss of balance is the balance responses will be improved in both training methods, but more in the random training method. We also hypothesize that brain function as seen in MRI will be improved in both training methods, more in the random training method.
As far as we know, there is a lack of studies investigating the learning effect of random vs. block non-random training on balance recovery responses while walking and exposure to unexpected loss of balance and on brain function.
Read the detailed description
Goals:
- Determine the relationship between gait stability (as measured in the Lab) and brain function (MRI) in 50 old (70 years old and over) and 10 young adults (20-40 years old) that represent heathy brain.
- To determine which of the training intervention methods (25 older adults that participate in random training vs. 25 older adults that participate in block non-random training) are more beneficial for balance recovery responses and for improved brain function.
Methods: This study is a clinical investigation study. First stage - Individuals that show an interest in participating in the study will be exposed to a brief interview before further testing is performed to see if they fit the inclusion-exclusion criteria. Individuals who pass the interview a screening, and physical examination and the additional questionnaires and functional tests described below.
Second stage - Testing different motor learning paradigms for improving balance recovery ability: A convenience sample of 60 healthy subjects (10 young's, 50 older adults) will be recruited. After testing their clinical balance performance (Berg balance test, 6-minutes' walk and get up and go) and cognitive function (MOCA), All testing will occur on a specific motor-driven surface perturbation treadmill (BaMPer). The Gait protocol will include about 10-20 minutes of comfortable pace walking, than progressive unexpected surface perturbations will be added. The same protocol will be performed with during standing condition. Subjects will also walk on the treadmill without perturbations. The order of the different test conditions will be randomized.
Outcome measures: The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation
(i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition, we will be testing the correlation between brain activity and anatomy using brain imaging in 10 young and 50 older adults and correlate with balance/motor function.
The aims of this study are to determine the relationship between the different requirements for gait stability (walking without perturbations, ability to overcome small perturbations, ability to overcome larger perturbations and, largest recoverable perturbation during walking) and brain function and anatomy. The research hypothesis: there is a correlation between the age related atrophies in areas of the brain and functional capacity
Third stage - A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.
- Conditions
- Old Adults
- Being tested
- perturbation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perturbation trainingBehavioural
A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Random perturbation training Receives: Behavioral: perturbation training |
| control group | Active comparator | Block perturbation training Receives: Behavioral: perturbation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The step recovery thresholds and brain imaging (MRI)
The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition we will be testing the correlation between brain activity using brain imaging in both to find whether improvement in motor function are correlated with brain function and anatomy.
Measured: 60 minute
Secondary outcomes (4)
Postural stability
participants will be instructed to stand upright on the force platform with the feet positioned as close as possible (heels and toes touching). A total of six 30-second trials will conduct for two visual conditions: eyes open and eyes closed. Balance measurements will be collected with a Kistler 9287 single force platform (Kistler Instrument Corp, Winterthur, Switzerland), which measures the time-varying displacement of the center of pressure (CoP) under the participant's feet. The force platform data will be sampled at a frequency of 100 Hz and stored on a hard disk for later processing.
Measured: 10 minutes
Voluntary step test
subjects will be instructed to step as quickly as possible following a cue signal
Measured: 6 minutes
Berg Balance test
The participant is scored on 14 balance tasks. Maximum score of 56 represents good balance. Higher scores indicate higher levels of balance function, while 45 or less indicates a high risk of falling.
Measured: 10 minutes
kinematics of walking
subjects will be instructed to walk on a treadmill. During the experiment we will measure by 3D motion analysis system gait kinematics during walking at their preferred speed for 2 minutes.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Oct 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Old AdultsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ilan Shelef, MD, Study chair, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455607
- Sponsor's protocol ID
- Sor 396-16 CTIL
- Acronym
- BalancING
- Status last verified
- Oct 2020
- First submitted
- 29 Jun 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paran I, Nachmani H, Salti M, Shelef I, Melzer I. Balance recovery stepping responses during walking were not affected by a concurrent cognitive task among older adults. BMC Geriatr. 2022 Apr 6;22(1):289. doi: 10.1186/s12877-022-02969-w.
PubMed 35387589Nachmani H, Paran I, Salti M, Shelef I, Melzer I. Examining Different Motor Learning Paradigms for Improving Balance Recovery Abilities Among Older Adults, Random vs. Block Training-Study Protocol of a Randomized Non-inferiority Controlled Trial. Front Hum Neurosci. 2021 Feb 25;15:624492. doi: 10.3389/fnhum.2021.624492. eCollection 2021.
PubMed 33716695
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Perturbation Training on Balance Recovery of Old Adults - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04455607
- Acronym / sponsor ID
- BalancING / Sor 396-16 CTIL
- Conditions
- Old Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Jul 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.
Falls are major contributors for immobility and independency. Most falls in older adults occur during walking after a sudden unexpected loss of balance. It was well-established that balance can be improved by performance of a training program that provides perturbation (unexpected perturbations of balance). The main aim of the current study is to investigate the effects of two perturbation-training methods: 1) random perturbation training; vs. 2) block (non-random) perturbation training. We also aim to explore brain area's (as measured by MRI) that are related to balance function in older adults.
We hypothesize that response to an unexpected loss of balance is the balance responses will be improved in both training methods, but more in the random training method. We also hypothesize that brain function as seen in MRI will be improved in both training methods, more in the random training method.
As far as we know, there is a lack of studies investigating the learning effect of random vs. block non-random training on balance recovery responses while walking and exposure to unexpected loss of balance and on brain function.
Detailed description
Goals:
- Determine the relationship between gait stability (as measured in the Lab) and brain function (MRI) in 50 old (70 years old and over) and 10 young adults (20-40 years old) that represent heathy brain.
- To determine which of the training intervention methods (25 older adults that participate in random training vs. 25 older adults that participate in block non-random training) are more beneficial for balance recovery responses and for improved brain function.
Methods: This study is a clinical investigation study. First stage - Individuals that show an interest in participating in the study will be exposed to a brief interview before further testing is performed to see if they fit the inclusion-exclusion criteria. Individuals who pass the interview a screening, and physical examination and the additional questionnaires and functional tests described below.
Second stage - Testing different motor learning paradigms for improving balance recovery ability: A convenience sample of 60 healthy subjects (10 young's, 50 older adults) will be recruited. After testing their clinical balance performance (Berg balance test, 6-minutes' walk and get up and go) and cognitive function (MOCA), All testing will occur on a specific motor-driven surface perturbation treadmill (BaMPer). The Gait protocol will include about 10-20 minutes of comfortable pace walking, than progressive unexpected surface perturbations will be added. The same protocol will be performed with during standing condition. Subjects will also walk on the treadmill without perturbations. The order of the different test conditions will be randomized.
Outcome measures: The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation
(i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition, we will be testing the correlation between brain activity and anatomy using brain imaging in 10 young and 50 older adults and correlate with balance/motor function.
The aims of this study are to determine the relationship between the different requirements for gait stability (walking without perturbations, ability to overcome small perturbations, ability to overcome larger perturbations and, largest recoverable perturbation during walking) and brain function and anatomy. The research hypothesis: there is a correlation between the age related atrophies in areas of the brain and functional capacity
Third stage - A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: perturbation trainingRandom perturbation training |
| control group | Active comparator | Behavioral: perturbation trainingBlock perturbation training |
Who may qualify
- Ages
- 70 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 70 years and older (with the young age of 20-40)
- able to walk independently (without utilities treadmill or stick);
- Be asked to invent a medical certificate which allows participation in exercise that requires walking twice a week.
Key exclusion criteria (5 listed)
- suffering from ischaemic heart disease which limits exercise and COPD and blood pressure is not controlled;
- not suffering serious vision problems;
- does not suffer from this problem: (a score of 24 or higher on MOCA);
- a year after analyzing the type of hip replacement or knee or broken extremities;
- Does not suffer any neurological diseases or stroke.
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 trainingA Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice. | Behavioural | control group, experimental group |
Primary outcome
The step recovery thresholds and brain imaging (MRI)
Time frame: 60 minute
The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition we will be testing the correlation between brain activity using brain imaging in both to find whether improvement in motor function are correlated with brain function and anatomy.
4 secondary outcomes
Postural stability
Time frame: 10 minutes
Voluntary step test
Time frame: 6 minutes
Berg Balance test
Time frame: 10 minutes
kinematics of walking
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 35387589Paran I, Nachmani H, Salti M, Shelef I, Melzer I. Balance recovery stepping responses during walking were not affected by a concurrent cognitive task among older adults. BMC Geriatr. 2022 Apr 6;22(1):289. doi: 10.1186/s12877-022-02969-w.
- Derived from this study: PubMed 33716695Nachmani H, Paran I, Salti M, Shelef I, Melzer I. Examining Different Motor Learning Paradigms for Improving Balance Recovery Abilities Among Older Adults, Random vs. Block Training-Study Protocol of a Randomized Non-inferiority Controlled Trial. Front Hum Neurosci. 2021 Feb 25;15:624492. doi: 10.3389/fnhum.2021.624492. eCollection 2021.
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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.
ilan Shelef, MD study chair
Soroka University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perturbation training in people with Old Adults, run by Soroka University Medical Center 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?
The sponsor lists 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The step recovery thresholds and brain imaging (MRI) (time frame: 60 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455607, which also lists 2 linked publications.
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 18 Apr 2024.