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Effects of Gait Rehabilitation With Dual Task in Patients With Parkinson's Disease (DUALGAIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038866
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborators:
Asociación Parkinson Valencia
Hospital Universitario La Fe
Information provided by (Responsible Party):
Constanza San Martín, University of Valencia

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DUAL-TASK

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Stride length [ Time Frame: 20 weeks ]
    distance measured between two consecutive heel strikes of the same foot (m)

  2. Cadence [ Time Frame: 20 weeks ]
    number of steps taken in a minute (steps·min-1)

  3. Double support time [ Time Frame: 20 weeks ]
    sum of the amount of time in which there is double-limb support in a walking cycle (%)

  4. 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 (°)

  5. Maximum hip extension [ Time Frame: 20 weeks ]
    maximum extension angle reached by the hip joint during the stance phase of the gait cycle (°)

  6. Maximum hip flexion [ Time Frame: 20 weeks ]
    maximum flexion angle reached by the hip joint during the swing phase of the gait cycle (°)

  7. 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

  8. 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)

  9. Anterior-posterior reaction force 1 [ Time Frame: 20 weeks ]
    milestone of anteroposterior component curve of reaction force that corresponds to the braking impulse



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic PD
  • To present Hoehn & Yahr stadium (H & Y) I, II or III
  • Minimum of two months without any kind of physical rehabilitation.
  • To be able to walk by themselves,
  • To have a normal cognitive state according to the Minimental test adapted for PD
  • Symmetry in lower limb length (<1cm).

Exclusion Criteria:

  • Presence of another symptomatic neurological or musculoskeletal disease
  • History of trauma or surgery on the lower limbs
  • Balance disorders due to other diseases
  • Uncontrolled chronic diseases (e.g. hypertension or diabetes).

Information from the National Library of Medicine

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


Locations
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Spain
University of Valencia, Faculty of Medicine, Unit of evaluation in personal autonomy, dependence and mental disorders
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Asociación Parkinson Valencia
Hospital Universitario La Fe
Investigators
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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
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Constanza San Martín, PhD Researcher at the Department of Medicine, Associate Professor at the Department of Physiotherapy, University of Valencia
ClinicalTrials.gov Identifier: NCT04038866    
Other Study ID Numbers: RCT_DUALGAIT
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

All the information of the study, as well as its results, will be shared in scientific publications and conferences related to the research area.

The information that is intended to be published in scientific journals includes: 1) Study Protocol, 2) Statistical Analysis, 3) Informed Consent Form, 4) Clinical Study Results.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Constanza San Martín, University of Valencia:
gait biomechanics
physical rehabilitation
physical therapy
dual task
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases