To conduct a feasibility study to test 1) whether focused and intensive dual task gait training leads to sustained improvements in complex gait performance. The study will focus hereby on influencing the ability to resist dual task interference, the…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurologische aandoening: ziekte van Parkinson
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is Dual Task (DT) gait performance. DT gait performance
will be evaluated by measuring gait speed at maximum levels while performing
untrained cognitive tasks. At baseline, the appropriate cognitive task
(sufficient level of cognitive challenge for each patient) will be determined
Secondary outcome
• Cognitive performance during dual task walking; amount of errors are scored
during the dual task assessment on the walkway.
• Gait performance during the trained cognitive tasks; as measured by the
GAITRite system.
• Dual task interference outcomes; by comparing the gait performance on the
single task and dual task assessment.
• Single task gait performance: speed, stride length and cadence; as measured
by the GAITRite system.
• Single task cognitive performance (during sitting); amount of errors is
scored during a single cognitive task which is similar to the cognitive task
that is used in the dual task test session.
Background summary
The ability to perform two or more tasks together - for instance walking and
talking - is impaired in Parkinson's Disease (PD). As a result, dual tasking
evokes gait deterioration with possibly an increased risk of falling. In the
European guideline for physiotherapy, it is therefore recommended to advise PD
patients to avoid dual tasking. However, based on clinical experience and pilot
work we argue that rather than avoiding, dual tasking should be trained and
that this intervention will not enhance fall risk. To establish the right
training method for this patientgroup two groups of integrated and consecutive
dual task training are being compared.
Study objective
To conduct a feasibility study to test 1) whether focused and intensive dual
task gait training leads to sustained improvements in complex gait performance.
The study will focus hereby on influencing the ability to resist dual task
interference, the ability to transfer learning effects to an untrained but
related task and the ability to retain the learning increments after a period
without training (12 weeks). 2) To test whether training dual task walking is a
safe intervention in PD and does not increase fall risk. And which training
method suits the patients best (integrated or consecutive dual task training).
3) To determine whether disease stage, disease profile (with and without
Freezing Of Gait) and cognitive factors predict the effect of dual task
training.
Study design
The design will consist of an international multi-centred, single blind,
randomized controlled trial.
Intervention
One hundred twenty subjects (sixty at each side) will receive a six week long
therapy intervention program consisting of integrated dual task training,four
times a week, for thirty minutes long. Twice a week this therapy will be guided
by an especially trained therapist and the other two times, the patients have
to practise by themselves. The consecutive dual task training group will
receive the same amount of therapy however consisting of traditional gait
training and separate training of cognitive tasks.
Study burden and risks
It is envisioned that this study will not involve any risks for the patients.
The testing procedures involve user-friendly equipment and mostly consist of
administration of clinical scales and tests. Testing will be carried out in a
standard movement laboratory setting. Measurement will be conducted in the
on-phase of the medication cycle. As put forward above, dual tasking may
distract attention and as such hamper gait performance. Therefore testing will
be performed under supervision of a physical therapist to ensure safety. At
home, training will be carried out by an experienced physiotherapist, who will
set the level of training to the abilities of the patient. In case of fall risk
patients will be advised to practice dual tasking on a safe level when
practising on their own. Training will be provided for free as the
physiotherapist will be employed by the project. Full reimbursement of
transport cost for the patients will be provided by the Duality-PD project.
Patients will be informed of the aims of study via an informed consent
procedure without biasing them towards one or the other protocol. Medication
intake and other interventions will be continued as normal. Only to assign the
measured effect to the *new* treatment the common therapy, if patients are
already receiving therapy, will be substituted for either the single or double
task intervention during the six week intervention period.
Reinier Postlaan 4
6525 GC Nijmegen
NL
Reinier Postlaan 4
6525 GC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
1) Diagnosis of Parkinson's disease based on UK Brain Bank criteria;
2) Hoehn & Yahr stage II-III in the on-phase;
3) Able to walk for 10 minutes continuously (FAC>4 *);
4) Dual task interference of at least 5% using a cognitive secondary task;
5) Without cognitive impairment (MoCA > 24+MMSE>24);
6) On stable medication;;* M.K. et al. (1984)
Functional Ambulation Category 4: Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces.
Exclusion criteria
1) Deep Brain stimulation; not an exclusion criteria when it is placed longer than a year ago and a stable result is being accomplished.
2) Severe medical conditions affecting gait;
3) Hearing and severe visual problems affecting testing;
4) Likely to change medication regimen;
5) Already receiving dual task training from their physiotherapist;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | nct01375473 |
CCMO | NL39530.091.12 |