Parkinson's DiseaseNCT01987557
Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease
A study testing rate group, magnitude treadmill group and regular treadmill walking in people with Parkinson's Disease and Treadmill, run by Wilfrid Laurier University.
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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Parkinson's Disease, Treadmill
- What is being tested?
- rate group, magnitude treadmill group and regular treadmill walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Parkinson's disease
- must be able to walk unassisted for 10 metres
Who cannot join
- cardiovascular disease/history of stroke
- Dementia
- lower body injury that would be worsened by repetitive walking
About this study
Official title: The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.
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.
- Conditions
- Parkinson's Disease, Treadmill
- Being tested
- rate group, magnitude treadmill group, regular treadmill walking
- Keywords
- treadmill, parkinson's, proprioception, cadence, step length, intrinsic feedback
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rate groupBehavioural
walking with a high cadence (steps per minute)
magnitude treadmill groupBehavioural
regular treadmill walkingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: magnitude treadmill group |
| regular treadmill walking | Placebo comparator | participants will walk at a comfortable self-selected pace on a treadmill Receives: Behavioral: regular treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lasswell, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987557
- Sponsor's protocol ID
- MDRC
- Status last verified
- Jun 2015
- First submitted
- 9 Oct 2013
- Last updated
- 17 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01987557
- Acronym / sponsor ID
- MDRC
- Conditions
- Parkinson's Disease, Treadmill
- Keywords
- treadmill, parkinson's, proprioception, cadence, step length, intrinsic feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 17 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treadmill Intervention 1: Rate Group | Experimental | Behavioral: rate groupParticipants 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 | Experimental | Behavioral: magnitude treadmill groupIn 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 comparator | Behavioral: regular treadmill walkingparticipants will walk at a comfortable self-selected pace on a treadmill |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of Parkinson's disease
- must be able to walk unassisted for 10 metres
Key exclusion criteria (3 listed)
- cardiovascular disease/history of stroke
- Dementia
- lower body injury that would be worsened by repetitive walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rate groupwalking with a high cadence (steps per minute) | Behavioural | Treadmill Intervention 1: Rate Group |
| magnitude treadmill group | Behavioural | Magnitude treadmill group |
| regular treadmill walking | Behavioural | regular treadmill walking |
Primary outcome
Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)
Time frame: 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
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).
2 secondary outcomes
Spatiotemporal Aspects of Gait
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing rate group, magnitude treadmill group and regular treadmill walking in people with Parkinson's Disease and Treadmill, run by Wilfrid Laurier University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.