Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987557
• Other study ID #: MDRC
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: June 12, 2015
• Start date: October 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2015
• Source: Wilfrid Laurier University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Wilfrid Laurier University Ethics Review Board: Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• diagnosis of Parkinson's disease

• must be able to walk unassisted for 10 metres

Exclusion Criteria:

• cardiovascular disease/history of stroke

• Dementia

• lower body injury that would be worsened by repetitive walking

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Treadmill

Intervention

Behavioral:
• rate group
walking with a high cadence (steps per minute)
• magnitude treadmill group

• regular treadmill walking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wilfrid Laurier University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Spatiotemporal Aspects of Gait	Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.; Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.; Spotters are always present to ensure safety during this assessment.	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.	No
Secondary	Static Posturography (Balance/Postural Control)	A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.	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.	No