Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease
The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.
1 other identifier
interventional
48
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
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, 2013
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
November 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
June 17, 2015
CompletedJune 17, 2015
June 1, 2015
10 months
October 9, 2013
February 18, 2015
June 12, 2015
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
Magnitude treadmill group
EXPERIMENTALIn 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
regular treadmill walking
PLACEBO COMPARATORparticipants will walk at a comfortable self-selected pace on a treadmill
Interventions
walking with a high cadence (steps per minute)
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
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