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Gait Improvement Strategies for Parkinson's Disease

N/A
Recruiting
Led By Chelsea P Duppen, DPT
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
Awards & highlights

Study Summary

This trial aims to find which approach is best for improving gait in people with Parkinson Disease: targeting gait or postural adjustments before gait. 10 adults with PD will compare two series of training.

Who is the study for?
This trial is for adults with Parkinson's Disease who have trouble starting to walk, can walk for more than 5 minutes without help, and are in the early-to-mid stages of the disease. They shouldn't have had recent orthopedic surgery, severe communication issues, ongoing supervised physical therapy, very slow walking speed, serious hearing or vision loss, other neurological problems affecting gait, dementia or traumatic brain injury.Check my eligibility
What is being tested?
The study tests two training methods to improve how people with Parkinson's start walking: one focuses on shifting body weight before stepping (postural control) and the other on practicing steady walking. Participants will try both methods in random order with a break between them to see which improves their first step better.See study design
What are the potential side effects?
Since this trial involves physical training exercises rather than medication or invasive procedures, side effects may include muscle soreness or fatigue related to exercise. There might also be an increased risk of falls during training sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
This trial's timeline: 3 weeks for screening, Varies for treatment, and conclusion of second training block, 1 week follow up from conclusion of second training block (1 week) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in First Step Length from Baseline to Conclusion of the first block of training
Change in First Step Length from conclusion of second training block to 1 week follow up from second training block
Change in First Step Length from end of first block of training to training 2 pre-test
+1 more
Secondary outcome measures
Change in First Step Speed from Baseline to Conclusion of the first block of training
Change in First Step Speed from end of first block of training to training 2 pre-test
Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Steady state gait training followed by postural control (weight shifting) training.Experimental Treatment2 Interventions
To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training. For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions. Each training will be three times per week for two weeks. There is a one week break between the two trainings.
Group II: Postural control (weight shifting) training followed by steady state gait training.Experimental Treatment2 Interventions
For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions. To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training. Each training will be three times per week for two weeks. There is a one week break between the two trainings.

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,032 Total Patients Enrolled
LSVT GlobalUNKNOWN
2 Previous Clinical Trials
2,010 Total Patients Enrolled
Michael Lewek, PhDStudy DirectorUNC Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the major goals of this clinical experiment?

"The primary target of this trial, to be measured within the first week of training, is a change in initial step length from baseline. The secondary objectives include alterations in mediolateral anticipatory postural adjustment (APA) size and speed between baseline and end of the first block of training as measured by center-of-pressure displacement towards stepping limb until toe off and division of initial step length by time taken for it respectively."

Answered by AI

Is this investigation encompassing individuals past the age of fifty?

"Patient recruitment is open to individuals aged between 35 and 99 years old."

Answered by AI

Who meets the eligibility criteria to participate in this trial?

"This trial is accepting 10 individuals with idiopathic Parkinson's and ages ranging from 35 to 99. To be considered, candidates must display two of the three cardinal signs (resting tremor, bradykinesia or rigidity), have a mild-moderate degree of gait/balance impairment as indicated by MDS Unified Parkinson disease Rating Scale items 10 and 12 respectively, report difficulty in freezing of gait as found on the Freezing of Gait Questionnaire question 3, and demonstrate an ability to walk for upwards 5 minutes at over 80% their comfortable gait speed both on a treadmill and without assistance while moving outside."

Answered by AI

Are there any vacancies available for enrolment in this research?

"This particular medical trial, which was first published on November 1st 2022 and last updated 15 days later, is not presently enrolling patients. Despite this, there are 489 other trials actively seeking participants at the present moment."

Answered by AI

Who else is applying?

What site did they apply to?
UNC Chapel Hill
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
2022. "How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625789.
~0 spots leftby Jun 2024
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