NCT01987557

Brief Summary

Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's disease (PD). The mechanisms for the therapeutic effects of treadmill training remain unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an important factor for achieving the reductions in motor scores. This study will compare a treadmill program that generates a high rate of intrinsic feedback to a treadmill program focused on generating a high magnitude of intrinsic feedback.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 17, 2015

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

October 9, 2013

Results QC Date

February 18, 2015

Last Update Submit

June 12, 2015

Conditions

Keywords

treadmillparkinson'sproprioceptioncadencestep lengthintrinsic feedback

Outcome Measures

Primary Outcomes (1)

  • Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)

    A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure. The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).

    Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined

Secondary Outcomes (2)

  • Spatiotemporal Aspects of Gait

    pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.

  • Static Posturography (Balance/Postural Control)

    pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.

Study Arms (3)

Treadmill Intervention 1: Rate Group

EXPERIMENTAL

Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.

Behavioral: rate group

Magnitude treadmill group

EXPERIMENTAL

In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs

Behavioral: magnitude treadmill group

regular treadmill walking

PLACEBO COMPARATOR

participants will walk at a comfortable self-selected pace on a treadmill

Behavioral: regular treadmill walking

Interventions

rate groupBEHAVIORAL

walking with a high cadence (steps per minute)

Treadmill Intervention 1: Rate Group
Magnitude treadmill group
regular treadmill walking

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Parkinson's disease
  • must be able to walk unassisted for 10 metres

You may not qualify if:

  • cardiovascular disease/history of stroke
  • Dementia
  • lower body injury that would be worsened by repetitive walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Matthew Lasswell
Organization
WilfridLU

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr. Matthew Lasswell

Study Record Dates

First Submitted

October 9, 2013

First Posted

November 19, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 17, 2015

Results First Posted

June 17, 2015

Record last verified: 2015-06