Accidental FallNCT04733222
Effect of Treadmill Perturbation Training on Falls
A study testing Perturbation training and Treadmill walking in people with Accidental Fall and Accident Prevention, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This parallel, randomized, controlled trial aims to quantify the effects of slip- and trip-perturbation training on fall rates collected over 12 months, compared to time-matched treadmill walking, among community-dwelling older adults (≥65 years). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Accident Prevention
- What is being tested?
- Perturbation training and Treadmill walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 15 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥65 years old
- Community-dwelling
- Able to walk without a walking aid
Who cannot join
- Any of the following self-reported conditions: Any orthopedic surgery within the past 12 months, osteoporosis or history of osteoporosis-related fractures (low impact hip, spine, and wrist fracture), or progressive neurological disease (e.g., Parkinson, multiple sclerosis)
- An unstable medical condition that would prevent safe participation
- Severe cognitive impairment (a score <8 in The Short Orientation-Memory-Concentration Test)
- Current participation in another fall prevention trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Treadmill Slip- and Trip-perturbation Training on Falls Among Community-dwelling Older Adults: A Randomized, Controlled Trial
This parallel, randomized, controlled trial aims to quantify the effects of slip- and trip-perturbation training on fall rates collected over 12 months, compared to time-matched treadmill walking, among community-dwelling older adults (≥65 years).
A sample size calculation estimated that 140 older community-dwelling older adults (≥65 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the perturbation or the walking group. The participants in the perturbation group will be assigned to four perturbation training sessions. The walking group will perform four treadmill walking matching the exercise time of the perturbation training. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from randomization. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess the circumstances and consequences (e.g., fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological outcomes will be made at baseline, post-test, six-month, and 12-months reassessment.
Read the detailed description
Approximately one-third of older adults fall at least once a year, and about 10% of these falls cause serious injuries such as head injuries and fractures. In fact, falls are the most frequent cause of injuries among older adults and often lead to disability, institutionalization, and premature death.
Multiple fall prevention interventions have been examined to reduce the fall rate, and physical exercise has continuously been proven as an effective and cost-effective approach. However, traditional exercise approaches, such as balance and muscle-strengthening training, have only shown a moderate 20-25% decrease in falls and encounters issues such as poor compliance. Recently, task-specific perturbation training using an overground walkway has been shown to produce quick motor adaptations resulting in improved pro- and reactive stability. Additionally, perturbation training delivered on such walkways has decreased both laboratory-induced and real-life falls. However, overground walkways with moveable platforms and trip-board are expensive and immobile; thus, limiting the clinical feasibility.
Contrarily, perturbation training delivered on computer-controlled treadmills may serve as a more implementable substitute. Preliminary studies have shown that treadmill perturbation training produces similar dynamic stability adaptations to overground perturbation training. Furthermore, a single session of treadmill perturbation decreases the rate of laboratory-induced falls, and the ergogenic effects were retained for up to six months. However, the effects of a brief treadmill perturbation training intervention on real-life falls in community-dwelling older adults still vastly unknown.
- Conditions
- Accidental Fall, Accident Prevention
- Being tested
- Perturbation training, Treadmill walking
- Keywords
- Aged, Aged, 80 and over, Exercise, Perturbation training, Older adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation trainingOther
The treadmill perturbation training will be performed on a computer-controlled treadmill. The perturbation will be induced by fast forward (slip) or backward (trip) accelerations of the treadmill at specific gait cycle timings. The perturbations will be delivered randomly to enhance the unpredictability. A ceiling-mounted body-harness ensures the safety of the participants.
Participants will be assigned to three initial sessions of treadmill slip- and trip-perturbation training on two days separated by a week and a "booster"-session after six months. On day 1, participants will first undergo a session 1 with 40 slip perturbations and then a session 2 with 40 trip perturbations. On day 2, participants will undergo a session 3 with 20 slip and 20 trip perturbations in random order. The "booster"-session after six months will be similar to session 3 (20 of each perturbation in random order).
Treadmill walkingOther
Participants allocated to the walking group will walk at a self-selected pace on a computer-controlled treadmill for the same amount of time as the treadmill perturbation training participants.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation training | Experimental | Participants randomized to the treadmill perturbation training will initially perform three sessions performed within a week followed by a "booster"-session after six months. Receives: Other: Perturbation training |
| Treadmill walking | Active comparator | Participants randomized to the walking group will undergo three initial sessions within a week and a "booster"-session after six months. Receives: Other: Treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rate
Falls are collected by daily recordings in calendar that is returned to the research group monthly
Measured: Continuously for 12 months after the initial three training sessions
Secondary outcomes (22)
Proportion of participants with at least one fall
Falls are collected by daily recordings in calendar that is returned to the research group monthly
Measured: Continuously for 12 months after the initial three training sessions
Time to first fall
Falls are collected by daily recordings in calendar that is returned to the research group monthly
Measured: Continuously for 12 months after the initial three training sessions
Fall-related fracture rate
When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. fractures). Screening of the participants medical records for radiologically verified fractures will verify this information.
Measured: Continuously for 12 months after the initial three training sessions
Proportion of participants with at least one fall-related fractures
When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. fractures). Screening of the participants medical records for radiologically verified fractures will verify this information.
Measured: Continuously for 12 months after the initial three training sessions
Number of all-cause fractures
Screening of the participants medical records for radiologically verified fractures.
Measured: At the 52-week follow-up
Number of other fall-related injuries
When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. head injuries and bruises).
Measured: Continuously for 12 months after the initial three training sessions
Fall-related hospital admission rate
When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. hospital contacts). Screening of the participant's medical records will verify this information.
Measured: Continuously for 12 months after the initial three training sessions
Proportion of participants with at least one hospital admission
When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. hospital contacts). Screening of the participant's medical records will verify this information.
Measured: Continuously for 12 months after the initial three training sessions
Number of all-cause hospital admissions
Screening of the participant's medical records
Measured: At the 52-week follow-up
Laboratory-induced falls
Falls after slips and trips induced on the treadmill. A fall is determined based on video recordings. A fall is defined as unambiguous support by the safety harness after the perturbation.
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Gait kinematics to perturbations
Gait kinematics collected before, during and after a slip- and trip-perturbation measured by heel contacts
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Single-task gait
8-meter walking timed by handheld stopwatch.
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Dual-task gait
8-meter walking timed by handheld stopwatch under dual-task condition (serial subtraction of threes from a random three digit number).
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Single-task static balance
30-seconds static balance measures on a Wii balance board.
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Dual-task static balance
30-seconds static balance measures on a Wii balance board under dual-task conditions (verbal fluency of grocery store items).
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Choice stepping reaction time
Choice stepping reactions test on a Wii balance board
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Lower extremity physical performance
The Short Physical Performance Battery
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Health-related quality of life
The EuroQoL EQ-5D-5L, Danish version
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Fear of Falling
The Short Falls Efficacy Scale International, Danish version
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Executive function
The trail making task Part A and B
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Frailty
The Tilburg Frailty Indicator
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Adverse events
Patient-reported events such as muscle soreness, discomfort, pain, or injuries
Measured: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies 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
- Model description
- After the pre-training tests, participants will be randomly allocated to either the perturation or control group. To produce groups of similar size a permuted block randomization will be used. Allocation concealment will be maintained using random block sizes (4, 6, or 8) and by the randomization code only being available for non-blinded research staff. The perturbation group will undergo three initial training sessions on two days within a week, and a "booster"-session after six months. The active control group will perform treadmill walking at a preferred speed to match the training dose of the perturbations group.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg Municipality, Aalborg University, Odense University Hospital, University of Southern Denmark
- Responsible party
- Principal investigator, Jens Eg Nørgaard, Aalborg University Hospital
- Investigators
- Jens Eg Nørgaard, MSc, Principal investigator, Aalborg University Hospital and Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733222
- Sponsor's protocol ID
- N-20200089
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norgaard JE, Andersen S, Ryg J, Andreasen J, Oliveira ASC, Stevenson AJT, Danielsen MBB, Jorgensen MG. Perturbation-based balance training of older adults and effects on physiological, cognitive and sociopsychological factors: a secondary analysis from a randomised controlled trial with 12-month follow-up. BMJ Open. 2024 Aug 7;14(8):e080550. doi: 10.1136/bmjopen-2023-080550.
PubMed 39117404Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Oliveira AS, Danielsen MB, Jorgensen MG. Effect of Treadmill Perturbation-Based Balance Training on Fall Rates in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e238422. doi: 10.1001/jamanetworkopen.2023.8422.
PubMed 37079305Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Danielsen MB, Oliveira ASC, Jorgensen MG. Effects of treadmill slip and trip perturbation-based balance training on falls in community-dwelling older adults (STABILITY): study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 7;12(2):e052492. doi: 10.1136/bmjopen-2021-052492.
PubMed 35131823
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treadmill Slip- and Trip-perturbation Training on Falls Among Community-dwelling Older Adults: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04733222
- Acronym / sponsor ID
- N-20200089
- Conditions
- Accidental Fall, Accident Prevention
- Keywords
- Aged, Aged, 80 and over, Exercise, Perturbation training, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg Municipality, Aalborg University, Odense University Hospital, University of Southern Denmark
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Feb 2021 (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.
This parallel, randomized, controlled trial aims to quantify the effects of slip- and trip-perturbation training on fall rates collected over 12 months, compared to time-matched treadmill walking, among community-dwelling older adults (≥65 years).
A sample size calculation estimated that 140 older community-dwelling older adults (≥65 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the perturbation or the walking group. The participants in the perturbation group will be assigned to four perturbation training sessions. The walking group will perform four treadmill walking matching the exercise time of the perturbation training. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from randomization. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess the circumstances and consequences (e.g., fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological outcomes will be made at baseline, post-test, six-month, and 12-months reassessment.
Detailed description
Approximately one-third of older adults fall at least once a year, and about 10% of these falls cause serious injuries such as head injuries and fractures. In fact, falls are the most frequent cause of injuries among older adults and often lead to disability, institutionalization, and premature death.
Multiple fall prevention interventions have been examined to reduce the fall rate, and physical exercise has continuously been proven as an effective and cost-effective approach. However, traditional exercise approaches, such as balance and muscle-strengthening training, have only shown a moderate 20-25% decrease in falls and encounters issues such as poor compliance. Recently, task-specific perturbation training using an overground walkway has been shown to produce quick motor adaptations resulting in improved pro- and reactive stability. Additionally, perturbation training delivered on such walkways has decreased both laboratory-induced and real-life falls. However, overground walkways with moveable platforms and trip-board are expensive and immobile; thus, limiting the clinical feasibility.
Contrarily, perturbation training delivered on computer-controlled treadmills may serve as a more implementable substitute. Preliminary studies have shown that treadmill perturbation training produces similar dynamic stability adaptations to overground perturbation training. Furthermore, a single session of treadmill perturbation decreases the rate of laboratory-induced falls, and the ergogenic effects were retained for up to six months. However, the effects of a brief treadmill perturbation training intervention on real-life falls in community-dwelling older adults still vastly unknown.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the pre-training tests, participants will be randomly allocated to either the perturation or control group. To produce groups of similar size a permuted block randomization will be used. Allocation concealment will be maintained using random block sizes (4, 6, or 8) and by the randomization code only being available for non-blinded research staff. The perturbation group will undergo three initial training sessions on two days within a week, and a "booster"-session after six months. The active control group will perform treadmill walking at a preferred speed to match the training dose of the perturbations group.
| Arm | Type | Receives |
|---|---|---|
| Perturbation training | Experimental | Other: Perturbation trainingParticipants randomized to the treadmill perturbation training will initially perform three sessions performed within a week followed by a "booster"-session after six months. |
| Treadmill walking | Active comparator | Other: Treadmill walkingParticipants randomized to the walking group will undergo three initial sessions within a week and a "booster"-session after six months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥65 years old
- Community-dwelling
- Able to walk without a walking aid
Key exclusion criteria (4 listed)
- Any of the following self-reported conditions: Any orthopedic surgery within the past 12 months, osteoporosis or history of osteoporosis-related fractures (low impact hip, spine, and wrist fracture), or progressive neurological disease (e.g., Parkinson, multiple sclerosis)
- An unstable medical condition that would prevent safe participation
- Severe cognitive impairment (a score <8 in The Short Orientation-Memory-Concentration Test)
- Current participation in another fall prevention trial
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 trainingThe treadmill perturbation training will be performed on a computer-controlled treadmill. The perturbation will be induced by fast forward (slip) or backward (trip) accelerations of the treadmill at specific gait cycle timings. The perturbations will be delivered randomly to enhance the unpredictability. A ceiling-mounted body-harness ensures the safety of the participants. Participants will be assigned to three initial sessions of treadmill slip- and trip-perturbation training on two days separated by a week and a "booster"-session after six months. On day 1, participants will first undergo a session 1 with 40 slip perturbations and then a session 2 with 40 trip perturbations. On day 2, participants will undergo a session 3 with 20 slip and 20 trip perturbations in random order. The "booster"-session after six months will be similar to session 3 (20 of each perturbation in random order). | Other | Perturbation training |
| Treadmill walkingParticipants allocated to the walking group will walk at a self-selected pace on a computer-controlled treadmill for the same amount of time as the treadmill perturbation training participants. | Other | Treadmill walking |
Primary outcome
Fall rate
Time frame: Continuously for 12 months after the initial three training sessions
Falls are collected by daily recordings in calendar that is returned to the research group monthly
22 secondary outcomes
Proportion of participants with at least one fall
Time frame: Continuously for 12 months after the initial three training sessions
Time to first fall
Time frame: Continuously for 12 months after the initial three training sessions
Fall-related fracture rate
Time frame: Continuously for 12 months after the initial three training sessions
Proportion of participants with at least one fall-related fractures
Time frame: Continuously for 12 months after the initial three training sessions
Number of all-cause fractures
Time frame: At the 52-week follow-up
Number of other fall-related injuries
Time frame: Continuously for 12 months after the initial three training sessions
Fall-related hospital admission rate
Time frame: Continuously for 12 months after the initial three training sessions
Proportion of participants with at least one hospital admission
Time frame: Continuously for 12 months after the initial three training sessions
Number of all-cause hospital admissions
Time frame: At the 52-week follow-up
Laboratory-induced falls
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Gait kinematics to perturbations
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Single-task gait
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Dual-task gait
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Single-task static balance
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Dual-task static balance
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Choice stepping reaction time
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Lower extremity physical performance
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Health-related quality of life
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Fear of Falling
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Executive function
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Frailty
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
Adverse events
Time frame: Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up)
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 1 Feb 2023.
- Derived from this study: PubMed 39117404Norgaard JE, Andersen S, Ryg J, Andreasen J, Oliveira ASC, Stevenson AJT, Danielsen MBB, Jorgensen MG. Perturbation-based balance training of older adults and effects on physiological, cognitive and sociopsychological factors: a secondary analysis from a randomised controlled trial with 12-month follow-up. BMJ Open. 2024 Aug 7;14(8):e080550. doi: 10.1136/bmjopen-2023-080550.
- Derived from this study: PubMed 37079305Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Oliveira AS, Danielsen MB, Jorgensen MG. Effect of Treadmill Perturbation-Based Balance Training on Fall Rates in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e238422. doi: 10.1001/jamanetworkopen.2023.8422.
- Derived from this study: PubMed 35131823Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Danielsen MB, Oliveira ASC, Jorgensen MG. Effects of treadmill slip and trip perturbation-based balance training on falls in community-dwelling older adults (STABILITY): study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 7;12(2):e052492. doi: 10.1136/bmjopen-2021-052492.
- 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.
Jens Eg Nørgaard, MSc principal investigator
Aalborg University Hospital and Aalborg University
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 Treadmill walking in people with Accidental Fall and Accident Prevention, run by Aalborg University Hospital at 1 site in Denmark.
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 4 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 1 Feb 2023. 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 Denmark. 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?
Fall rate (time frame: Continuously for 12 months after the initial three training sessions). 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 NCT04733222, which also lists 3 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 1 Feb 2023.