Balance Control in ElderlyNCT07195526
Getting Seniors Back on Their Bicycle; a Pretest-posttest Case-control Study on the Improvement of Bicycle Balance Control
A study of Balance Control in Elderly, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
Trial summary
This study investigates the effectiveness of an intervention that aims at restoring bicycle balance control skills in seniors that have quit cycling. The intervention will last 11 weeks and involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Balance Control in Elderly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Mar 2023to 6 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons that stopped cycling at least six months ago and want to get back on their bicycle.
Who cannot join
- Balance-relevant sensory disorders (peripheral neuropathy, labyrinthitis, vestibular neuritis, …)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Faculty of Social Sciences Research labs and Radboud University Sports Center
Nijmegen, 6500 HE
About this study
This study investigates the effectiveness of an intervention that aims at restoring bicycle balance control skills in seniors that have quit cycling. The intervention will last 11 weeks and involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.
- Conditions
- Balance Control in Elderly
- Being tested
- Bicycle balance control training
- Keywords
- Balance control, bicycle balance, motor skill training, mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle balance control trainingBehavioural
The intervention involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.
| Study group | Role | What they receive |
|---|---|---|
| Bicycle balance control training | Experimental | The intervention involveds three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that will be practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control was increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads. Receives: Behavioral: Bicycle balance control training |
| Control group | No intervention | The participants in the experimental group are matched to the participants in the control group. The control group participants are selected based on their distance from the location of the intervention; control group participants live farther away from the location of the intervention as compared to the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bicycle balance control skill and confidence
This outcome variable will be obtained from a questionnaire that evaluates participants' bicycle BC skills and confidence while riding on the public roads. For each of three environments (without traffic, little traffic, busy traffic), participants must indicate what applies to them: (1) "I did not ride my bicycle here", (2) "I rode my bicycle here, but I try to avoid it", and (3) "I rode my bicycle here without problems". The answers to every question/environment were converted into a score by assigning 0, 1, and 2 points to the respective options. Summing these scores over the three questions/environments results in a number between 0 and 6, which is the outcome variable.
Measured: Pretest: Between the second and the third week of June 2023 Posttest: First week of October 2023
Secondary outcomes (1)
One-minute functional threshold power (1minFTP)
The 1minFTP is the highest power a participant can maintain for one minute while cycling at 60 revolutions per minute (RPM). The 1minFTP was assessed by having participants monitor their breath after a one-minute effort at some power level: if the participant can say only a few words at a time (a proxy for reaching the ventilatory threshold), the 1minFTP is reached.
Measured: From the third week of June 2023 until the second week of August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start31 Mar 2023
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance Control in ElderlyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donders Centre for Cognitive Neuroimaging
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Maris, Donders Centre for Cognitive Neuroimaging
- Investigators
- Eric Maris, PhD, Principal investigator, Donders Centre for Cognitive Neuroimaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195526
- Sponsor's protocol ID
- DCC.2024.00080
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 26 Sep 2025
- 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 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting Seniors Back on Their Bicycle; a Pretest-posttest Case-control Study on the Improvement of Bicycle Balance Control
- ClinicalTrials.gov ID
- NCT07195526
- Acronym / sponsor ID
- DCC.2024.00080
- Conditions
- Balance Control in Elderly
- Keywords
- Balance control, bicycle balance, motor skill training, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Donders Centre for Cognitive NeuroimagingUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 26 Sep 2025 (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 study investigates the effectiveness of an intervention that aims at restoring bicycle balance control skills in seniors that have quit cycling. The intervention will last 11 weeks and involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicycle balance control training | Experimental | Behavioral: Bicycle balance control trainingThe intervention involveds three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that will be practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control was increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads. |
| Control group | No intervention | –The participants in the experimental group are matched to the participants in the control group. The control group participants are selected based on their distance from the location of the intervention; control group participants live farther away from the location of the intervention as compared to the experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Persons that stopped cycling at least six months ago and want to get back on their bicycle.
Key exclusion criteria (1 listed)
- Balance-relevant sensory disorders (peripheral neuropathy, labyrinthitis, vestibular neuritis, …)
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 |
|---|---|---|
| Bicycle balance control trainingThe intervention involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads. | Behavioural | Bicycle balance control training |
Primary outcome
Bicycle balance control skill and confidence
Time frame: Pretest: Between the second and the third week of June 2023 Posttest: First week of October 2023
This outcome variable will be obtained from a questionnaire that evaluates participants' bicycle BC skills and confidence while riding on the public roads. For each of three environments (without traffic, little traffic, busy traffic), participants must indicate what applies to them: (1) "I did not ride my bicycle here", (2) "I rode my bicycle here, but I try to avoid it", and (3) "I rode my bicycle here without problems". The answers to every question/environment were converted into a score by assigning 0, 1, and 2 points to the respective options. Summing these scores over the three questions/environments results in a number between 0 and 6, which is the outcome variable.
1 secondary outcome
One-minute functional threshold power (1minFTP)
Time frame: From the third week of June 2023 until the second week of August 2023
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 26 Sep 2025.
- 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.
Eric Maris, PhD principal investigator
Donders Centre for Cognitive Neuroimaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Balance Control in Elderly, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
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 1 inclusion and 1 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 26 Sep 2025. 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 Netherlands. 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?
Bicycle balance control skill and confidence (time frame: Pretest: Between the second and the third week of June 2023 Posttest: First week of October 2023). 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 26 Sep 2025.