NCT03902990

Brief Summary

The ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable parkinson-disease

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

October 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

April 3, 2019

Last Update Submit

April 3, 2019

Conditions

Parkinson Disease

Keywords

dual task, treadmill, cognitive rehabilitation

Outcome Measures

Primary Outcomes (4)

  • 10MWT

    10 Meter Walk Test on comfortable speed

    12 weeks

  • 10MWT with cognitive tasks

    10 Meter Walk Test with cognitive tasks

    12 weeks

  • MoCA

    Montreal Cognitive Assessment

    12 weeks

  • TUG

    Timed Up and Go Test

    12 weeks

Secondary Outcomes (5)

  • PDQ-39

    12 weeks

  • FES-I

    12 weeks

  • Stroop Test

    12 weeks

  • FOGQ

    12 weeks

  • Falls Diary

    4 weeks

Study Arms (3)

Dual task

EXPERIMENTAL

Treadmill training + cognitive tasks + standard exercise programme

Other: Dual taskOther: Treadmill TrainingOther: Standard exercise programme

Single task

ACTIVE COMPARATOR

Treadmill training + standard exercise programme

Other: Treadmill TrainingOther: Standard exercise programme

Control

ACTIVE COMPARATOR

Standard exercise programme

Other: Standard exercise programme

Interventions

Dual taskOTHER

The patients in the dual task group received cognitive tasks during treadmill training sessions.

Dual task
Treadmill TrainingOTHER

Standard treadmill training

Dual taskSingle task
Standard exercise programmeOTHER

Standard exercise programme for Parkinson Disease

ControlDual taskSingle task

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with Idiopathic Parkinson Disease on medication who has
  • Hoehn-Yahr 1-3
  • Mini Mental Test score 20 and above
  • Functional Ambulation Category 2 and above
  • No changes in medication in last 3 months
  • No rehabilitation programme in last 3 months

You may not qualify if:

  • Diagnosis of Parkinsonism other than Idiopathic Parkinson Disease
  • Global aphasia
  • Severe cognitive dysfunction
  • Other neurologic/orthopedic diseases
  • Limiting cardiovascular or pulmonary disease
  • Visual impairment
  • Hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ayse Yaliman, Prof

    Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation

    STUDY DIRECTOR

  • Ekin Ilke Sen, MD

    Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this prospective, randomized, controlled, double-blinded study the patients were randomized to three groups as; dual-task group, single-task group and control group. All of the patients were scheduled on standard exercise programme. The patients in dual-task group received treadmill training with cognitive tasks and the patients in single-task group received treadmill training alone in addition to standard exercise programme. The training was scheduled as 30 minute sessions under supervision of a specialist, three times in a week for four weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 4, 2019

Study Start

October 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)