NCT02025517

Brief Summary

Treadmill gait training combined with cognitive tasks in Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
Last Updated

January 1, 2014

Status Verified

November 1, 2012

Enrollment Period

1 month

First QC Date

December 13, 2013

Last Update Submit

December 27, 2013

Conditions

Keywords

Parkinson's diseaserehabilitationkinematicscognition

Outcome Measures

Primary Outcomes (1)

  • Changes in kinematic gait parameters after treadmill training

    The treadmill training was realized for 20 minutes. Immediately after treadmill training, kinematic gait data were captured by Qualisys Track Manager software and exported to Visual 3D, to reconstruct the segments and create a biomechanical model. It was carried out in two stages: static and dynamic collection. The primary outcome measure was the kinematic variables at the phase post training on treadmill. The kinematic variables include: speed (m/s), cadence (steps/min), stride length (m), step length (m) and angular displacement (º).

    Immediately after gait training on treadmill.

Study Arms (2)

Without Cognitive Tasks

NO INTERVENTION

Gait training on treadmill during 20 minutes.

Cognitive Tasks

EXPERIMENTAL

Treadmill training plus cognitive verbal fluency, memory and spatial planning tasks, during 20 minutes.

Other: Cognitive Tasks.

Interventions

The Experimental Group underwent treadmill gait training simultaneously to a protocol of cognitive tasks created specifically for this study, based on cognitive activities proposed in previous studies. The training sessions lasted 20 minutes. The first three minutes allowed subjects to familiarize themselves with the treadmill. From the 4th minute onward, the volunteer walked for 1 minute while performing cognitive tasks, and in the following minute, only walked. Thus, the 17 remaining minutes on the treadmill alternated between one minute of treadmill training combined with a cognitive task and the following minute only treadmill training. Treadmill gait speed was that reported by the patient as the fastest possible speed while maintaining a suitable comfort level.

Cognitive Tasks

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic PD by a neurologist and confirmed by complementary examinations;
  • Degree of disease progression equivalent to stages 2 to 3 of the Modified Hoehn and Yahr Scale;
  • Regular use of antiparkinson medication, exhibiting stable response; able to walk independently without ortheses or other assistive devices;
  • Absence of brain stimulation surgery; absence of cardiovascular, respiratory and musculoskeletal diseases that could compromise performance during assessment and training;
  • Absence of other neurological disorders;
  • Absence of non-corrected visual or auditory disturbances;
  • Be able to understand verbal instructions; being literate;
  • Give their written informed consent.

You may not qualify if:

  • Blood pressure above 140X90 mmHg before the intervention (values referring to the first stage of hypertension);
  • Heart rate above the submaximal value, calculated by the formula 0.75 x (220-age), during the intervention;
  • Feeling nauseous or experiencing persistent acute pain during the exercises; - Voluntarily abandoning the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59078-970, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Angelica VC Sousa, Master

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ana Raquel Rodrigues Lindquist

Study Record Dates

First Submitted

December 13, 2013

First Posted

January 1, 2014

Study Start

August 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 1, 2014

Record last verified: 2012-11

Locations