Effects of Gait Rehabilitation With Dual Task in Patients With Parkinson's Disease (DUALGAIT)
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|ClinicalTrials.gov Identifier: NCT04038866|
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : December 10, 2019
In functional environments, dual-tasks (DT) are common and require a correct motor and cognitive performance to be carried out successfully. In people with neurodegenerative diseases such as Parkinson's disease (PD), to walk with a secondary task affects gait. The inclusion of DT to the assessment and physical rehabilitation of patients allows to simulate day-to-day contexts in a controlled and safe environment and consequently, extrapolate more easily the advances of rehabilitation to daily life.
This project studied the effects of a gait rehabilitation program with dual tasks (DUALGAIT) in patients with Parkinson's disease and compared the results with a control active group of patients who performed a general physical rehabilitation program (without dual-task and only motor exercise practice).
The investigator's hypothesis is that gait training under dual conditions has a greater effect than traditional motor physiotherapy programs on the biomechanics of parkinsonian gait.
The present study is a randomized controlled clinical trial, with evaluators blind to the allocation of participants in the different groups.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: rehabilitation gait with dual task Other: rehabilitation gait without dual task||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients were randomized into two groups: control and experimental. Both groups performed different physical therapy programs to rehabilitate gait, in the experimental group they were included dual tasks during the walking exercises. Control and experimental group developed the rehabilitation programs at the same time.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The physiotherapists who assessment gait before and after interventions (post and follow-up) did not know to which group each patient belonged.|
|Official Title:||Effects of Gait Rehabilitation With Dual Task in Patients With Parkinson's Disease: a Randomized Controlled Trial|
|Actual Study Start Date :||June 14, 2014|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
Patients with Parkinson's disease who carry out the rehabilitation gait with a dual-task program with secondary cognitive and upper limb motor tasks.
In this group, the training of the tasks (walking and cognitive or motor) was performed separately and then they were trained at the same time under a progression system. Cognitive/motor secondary tasks were different from those used in the assessment of gait.
Each training session consisted of three parts: the initial warm-up, dual-training, and back-to-calm.
Other: rehabilitation gait with dual task
Active Comparator: SINGLE-TASK
Patients with Parkinson's disease who carry out the rehabilitation gait without a dual-task program (physical and walking exercises without additional load of cognitive or upper limb motor tasks).
Each training session consisted of three parts: initial warm-up, physical exercise in single-task condition, and back-to-calm.
The objectives and walking exercises were the same as those performed in the experimental group.
Other: rehabilitation gait without dual task
- Velocity [ Time Frame: 20 weeks (time that includes 10 weeks of training, 8 weeks of follow-up and one week before and after the entire study to perform the Basal and Follow-up measurements) ]distance travelled by the body per unit of time (m·s-1)
- Stride length [ Time Frame: 20 weeks ]distance measured between two consecutive heel strikes of the same foot (m)
- Cadence [ Time Frame: 20 weeks ]number of steps taken in a minute (steps·min-1)
- Double support time [ Time Frame: 20 weeks ]sum of the amount of time in which there is double-limb support in a walking cycle (%)
- range of motion of the ankle [ Time Frame: 20 weeks ]sum of maximum angle of plantar flexion and maximum angle of dorsiflexion of the foot (°)
- Maximum hip extension [ Time Frame: 20 weeks ]maximum extension angle reached by the hip joint during the stance phase of the gait cycle (°)
- Maximum hip flexion [ Time Frame: 20 weeks ]maximum flexion angle reached by the hip joint during the swing phase of the gait cycle (°)
- Vertical reaction force 1 [ Time Frame: 20 weeks ]milestone of the vertical component curve of reaction forces corresponding to the heel strike of the gait cycle
- Vertical reaction force 2 [ Time Frame: 20 weeks ]milestone of the vertical component curve of reaction forces corresponding to the mid stance of the gait cycle (N)
- Anterior-posterior reaction force 1 [ Time Frame: 20 weeks ]milestone of anteroposterior component curve of reaction force that corresponds to the braking impulse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038866
|University of Valencia, Faculty of Medicine, Unit of evaluation in personal autonomy, dependence and mental disorders|
|Valencia, Spain, 46010|
|Principal Investigator:||Constanza I San Martín Valenzuela, PhD||Faculty of Medicine, University of Valencia|
|Study Director:||Pilar Serra Añó, PhD||Faculty of Physiotherapy, University of Valencia|
|Study Director:||José Manuel Tomás Miguel, PhD||Faculty of Psychology, University of Valencia|