|- candidate number||13335|
|- NTR Number||NTR3619|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-sep-2012|
|- Secondary IDs||42027 CCMO|
|- Public Title||Does ageing influence cycling behaviour and stability?|
|- Scientific Title||Analysis of elderly cycling behaviour, fall risk and the relationship with physical and cognitive abilities.|
|- hypothesis||Background: |
Injury rate and injury severity of elderly cyclists due to self-induced cycle accidents increase with age. Starting at the age of 55 years, injury risk increases with a factor 4 at the age of 75 years. Injury mechanisms such as slippery roads and poles have been identified, however little is known about the underlying personal factors.
Analyse the cycling behavior of elderly cyclists and improve our understanding of the influencing physical and cognitive factors.
Degeneration of physical and cognitive abilities results in changes in cycling behaviour and more instable cycling situations.
|- Healt Condition(s) or Problem(s) studied||Older adults, Aging, Cycling, Stability, Mental degeneration, Physical degeneration|
|- Inclusion criteria||1. Maximum age of 40 years for the 'Young' and min 65 years for both Élderly' groups;|
2. No self-induced cycling falls occured for the 'Young' and 'Elderly' group; and 1 or more self-induced cycling falls occured during the last year for the 'Elderly-at risk' group;
3. Regular cycling experience (2-3 times per week);
4. The ability to cycle for 20 minutes on a non-electric bicycle;
5. Adequate visual and auditive functions to understand the experiments, follow instructions and give feedback to the researchers.
|- Exclusion criteria||1. Serious visual or auditive impairments;|
2. History of bicycle fall (s) resulting in serious injuries.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-jul-2015|
|- Target number of participants||55|
|- Primary outcome||1. Lateral sway of the cyclist with respect to the bicycle;|
2. Lateral acceleration;
3. Lateral sway and steer angle of the bicycle.
|- Secondary outcome||1. Reaction time;|
2. Short term memory;
3. Balance ability;
4. Knee proprioception;
5. Hand grip strength;
6. Cycling velocity.
|- Timepoints||For each subject, the clinical tests and cycling test will be performed within two weeks time.
1. Movement sensors to asses the movements of the bicycle and cyclist (primary outcome measures);
2. Clinical questionnaires to asses balance (Berg balans), short-term memory (15 words test) and general health status (SF-36);
3. Lanodolt C –visus chart to asses the visual ability;
4. Questionnaire with Visual Analog Score (VAS) to asses subjective cycling experience;
5. Handheld dynamometer to asses handgripstrength;
6. Velocity and cadance measurement devices to asses cycling velocity and pedal frequency;
7. Reaction time Vienna-testsysteem.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Rosemary Dubbeldam|
|- CONTACT for SCIENTIFIC QUERIES|| Rosemary Dubbeldam|
|- Sponsor/Initiator ||Roessingh Research and Development b.v., University of Twente|
(Source(s) of Monetary or Material Support)
|Ministry of Economic Affairs|
|- Brief summary||Rationale: |
Cycling is a natural, highly accepted and often used mode of transportation in The Netherlands. However, the incident rate and injury severity of bicycle accidents increase with age. Similar findings have been reported internationally and the corresponding mechanisms resulting in bicycle accidents, such as getting on and off the bicycle and ground irregularities, have been analysed. However, the causes for the accidents, like cycling behaviour, muscle weakness and balance or reaction problems have not yet been studied.
The aim of this study is to record and analyse cycling kinematics, subjective and objective stability and balance strategies of elderly cyclists and compare them to younger subjects. Furthermore, the aim of this study is to analyse the relationship between physical and cognitive abilities of elder cyclists and their cycle stability.
This study has a cross-sectional design, with one measurement session (T1) for assessing the kinematics and clinical scores of the younger and elderly subjects.
15 younger subjects (<40 years old) and two groups with each 20 elderly subjects (>65 years old): A control group and a fall-risk group.
Intervention: No intervention will be applied.
Main study parameters/endpoints:
The main study parameter of the present experiment is the lateral bicycle sway. This kinematic measure is used to evaluate the influence of natural aging on cycling performance.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risks for the subjects are limited, since the cycling tasks represent functional and familiar movements and are performed only within the scope of the subject’s ability. The clinical tests are performed before the cycling tests, so insight in the subject’s abilities will be available beforehand. During the cycling tests the difficulty in task increases slowly and can be stopped, by the subject self or by the therapist, at any time. In addition, the measurements used in this study (kinematics, clinical scores) are all noninvasive and involve no risks to the subjects in any way.
Participation of a subject in this experiment has no direct benefit for him/her, other than expanding knowledge about underlying mechanisms of motor control of cycling and aiding in development of sophisticated tools to improve bicycle stability.
|- Main changes (audit trail)|
|- RECORD||19-sep-2012 - 6-okt-2012|