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Physiotherapy for Parkinson's Disease

N/A

Recruiting

Led By Alfonso Fasano, MD, PhD

Research Sponsored by University of Toronto

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 visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8

Awards & highlights

Study Summary

This trial is testing whether adding physical therapy to standard deep brain stimulation surgery helps improve mobility for people with Parkinson’s disease, beyond what surgery alone can achieve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8 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 mobility measures

Secondary outcome measures

Anxiety

Balance

Balance confidence

+7 more

Other outcome measures

Exploratory outcome - average number of steps

Exploratory outcome - distance

Exploratory outcome - heart rate

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physiotherapy groupExperimental Treatment1 Intervention

Participants assigned to the physiotherapy group will receive physiotherapy treatment at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks. They will begin to receive the physiotherapy treatment at 4 months following their surgery and once their DBS settings are optimized.

Group II: Control groupActive Control1 Intervention

Participants assigned to the control group will not receive any additional intervention and will be precluded from starting formal physiotherapy for the duration of the study. However, they will be encouraged to keep an active lifestyle. In order to stay active, they will be recommended to do simple home exercises following a home exercise video that will be presented to them. They will be asked to do it 3 times/week for 8 weeks and keep an exercise log to help them stay on track.

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Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

689 Previous Clinical Trials

1,018,583 Total Patients Enrolled

Alfonso Fasano, MD, PhDPrincipal InvestigatorUniversity of Toronto

3 Previous Clinical Trials

68 Total Patients Enrolled

Media Library

Deep Brain Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04953637 — N/A

Parkinson's Disease Research Study Groups: Physiotherapy group, Control group

Parkinson's Disease Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT04953637 — N/A

Deep Brain Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04953637 — N/A

Frequently Asked Questions

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

How many participants are currently involved in this research?

"Affirmative. According to clinicaltrials.gov, this experiment is presently searching for volunteers and was first announced on April 15th 2021 with the last edit being October 31st 2022. The trial needs 60 individuals from one clinic site."

Answered by AI

Is recruitment of participants currently in progress for this experiment?

"Affirmative. Clinicaltrials.gov supports the notion that this research project, which commenced on April 15th 2021, is actively seeking volunteers. 60 participants need to be enrolled in 1 medical facility."

Answered by AI