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

NCT04038866 | Completed

• 1 other identifier: RCT_DUALGAIT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

gait biomechanics; physical rehabilitation; physical therapy; dual task

Outcome Measures

Primary Outcomes (1)

• Velocity

  distance travelled by the body per unit of time (m·s-1)

  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)

Secondary Outcomes (9)

• Stride length

  20 weeks

• Cadence

  20 weeks

• Double support time

  20 weeks

• range of motion of the ankle

  20 weeks

• Maximum hip extension

  20 weeks

Study Arms (2)

DUAL-TASK

EXPERIMENTAL

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

SINGLE-TASK

ACTIVE COMPARATOR

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

Interventions

rehabilitation gait with dual task OTHER

DUAL-TASK

rehabilitation gait without dual task OTHER

SINGLE-TASK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Valencia: lead
• Asociación Parkinson Valencia: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (1)

University of Valencia, Faculty of Medicine, Unit of evaluation in personal autonomy, dependence and mental disorders

Valencia, 46010, Spain

Location

Related Publications (13)

• Strouwen C, Molenaar EA, Keus SH, Munks L, Munneke M, Vandenberghe W, Bloem BR, Nieuwboer A. Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial. BMC Neurol. 2014 Mar 27;14:61. doi: 10.1186/1471-2377-14-61.

  PMID: 24674594 BACKGROUND

• Brauer SG, Woollacott MH, Lamont R, Clewett S, O'Sullivan J, Silburn P, Mellick GD, Morris ME. Single and dual task gait training in people with Parkinson's disease: a protocol for a randomised controlled trial. BMC Neurol. 2011 Jul 27;11:90. doi: 10.1186/1471-2377-11-90.

  PMID: 21791117 BACKGROUND

• Geroin C, Nonnekes J, de Vries NM, Strouwen C, Smania N, Tinazzi M, Nieuwboer A, Bloem BR. Does dual-task training improve spatiotemporal gait parameters in Parkinson's disease? Parkinsonism Relat Disord. 2018 Oct;55:86-91. doi: 10.1016/j.parkreldis.2018.05.018. Epub 2018 May 18.

  PMID: 29802080 RESULT

• Strouwen C, Molenaar EALM, Munks L, Broeder S, Ginis P, Bloem BR, Nieuwboer A, Heremans E. Determinants of Dual-Task Training Effect Size in Parkinson Disease: Who Will Benefit Most? J Neurol Phys Ther. 2019 Jan;43(1):3-11. doi: 10.1097/NPT.0000000000000247.

  PMID: 30531381 RESULT

• Strouwen C, Molenaar EALM, Munks L, Keus SHJ, Zijlmans JCM, Vandenberghe W, Bloem BR, Nieuwboer A. Training dual tasks together or apart in Parkinson's disease: Results from the DUALITY trial. Mov Disord. 2017 Aug;32(8):1201-1210. doi: 10.1002/mds.27014. Epub 2017 Apr 25.

  PMID: 28440888 RESULT

• Fok P, Farrell M, McMeeken J. The effect of dividing attention between walking and auxiliary tasks in people with Parkinson's disease. Hum Mov Sci. 2012 Feb;31(1):236-46. doi: 10.1016/j.humov.2011.05.002. Epub 2011 Jul 1.

  PMID: 21723639 RESULT

• Fok P, Farrell M, McMeeken J. Prioritizing gait in dual-task conditions in people with Parkinson's. Hum Mov Sci. 2010 Oct;29(5):831-42. doi: 10.1016/j.humov.2010.06.005. Epub 2010 Aug 19.

  PMID: 20727609 RESULT

• Yogev-Seligmann G, Giladi N, Brozgol M, Hausdorff JM. A training program to improve gait while dual tasking in patients with Parkinson's disease: a pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):176-81. doi: 10.1016/j.apmr.2011.06.005. Epub 2011 Aug 17.

  PMID: 21849167 RESULT

• Mirelman A, Maidan I, Herman T, Deutsch JE, Giladi N, Hausdorff JM. Virtual reality for gait training: can it induce motor learning to enhance complex walking and reduce fall risk in patients with Parkinson's disease? J Gerontol A Biol Sci Med Sci. 2011 Feb;66(2):234-40. doi: 10.1093/gerona/glq201. Epub 2010 Nov 24.

  PMID: 21106702 RESULT

• Brauer SG, Morris ME. Can people with Parkinson's disease improve dual tasking when walking? Gait Posture. 2010 Feb;31(2):229-33. doi: 10.1016/j.gaitpost.2009.10.011. Epub 2009 Dec 6.

  PMID: 19969461 RESULT

• Canning CG, Ada L, Woodhouse E. Multiple-task walking training in people with mild to moderate Parkinson's disease: a pilot study. Clin Rehabil. 2008 Mar;22(3):226-33. doi: 10.1177/0269215507082341.

  PMID: 18285432 RESULT

• San Martin Valenzuela C, Moscardo LD, Lopez-Pascual J, Serra-Ano P, Tomas JM. Effects of Dual-Task Group Training on Gait, Cognitive Executive Function, and Quality of Life in People With Parkinson Disease: Results of Randomized Controlled DUALGAIT Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1849-1856.e1. doi: 10.1016/j.apmr.2020.07.008. Epub 2020 Aug 12.

  PMID: 32795562 DERIVED

• San Martin Valenzuela C, Duenas Moscardo L, Lopez-Pascual J, Serra-Ano P, Tomas JM. Interference of functional dual-tasks on gait in untrained people with Parkinson's disease and healthy controls: a cross-sectional study. BMC Musculoskelet Disord. 2020 Jun 22;21(1):396. doi: 10.1186/s12891-020-03431-x.

  PMID: 32571284 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Constanza I San Martín Valenzuela, PhD

  Faculty of Medicine, University of Valencia

  PRINCIPAL INVESTIGATOR

• Pilar Serra Añó, PhD

  Faculty of Physiotherapy, University of Valencia

  STUDY DIRECTOR

• José Manuel Tomás Miguel, PhD

  Faculty of Psychology, University of Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physiotherapists who assessment gait before and after interventions (post and follow-up) did not know to which group each patient belonged.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher at the Department of Medicine, Associate Professor at the Department of Physiotherapy

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 31, 2019
• Study Start: June 14, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)