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Clinical Trials/NCT04918342
NCT04918342CompletedNot Applicable

Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease

Ithaca College1 site in 1 country20 target enrollmentStarted: June 7, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in "Mini-Balance Evaluation Systems Test" Score

Study Overview

Brief Summary

This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.

Detailed Description

This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •have a diagnosis of idiopathic Parkinson disease
  • •been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
  • •be able to walk independently
  • •have a referral from a physician to participate in the program
  • •have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform

Exclusion Criteria

  • •have any other neurological condition other than Parkinson disease
  • •have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
  • •demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
  • •have any musculoskeletal condition that affected their ability to participate in the exercise group
  • •score less than 24/30 on the Mini Mental Status Examination during the initial evaluation

Arms & Interventions

Individual Exercise Instruction

Active Comparator

The participant will receive individual exercise instruction.

Intervention: Multidimensional Exercise Program (Other)

Group Exercise Instruction

Experimental

The participant will receive the instruction in a group of up to 9 other participants.

Intervention: Multidimensional Exercise Program (Other)

Outcomes

Primary Outcomes

Change in "Mini-Balance Evaluation Systems Test" Score

Time Frame: Prior to and after the 8 week intervention.

This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.

Change in "Five Times Sit to Stand" test time

Time Frame: Prior to and after the 8 week intervention.

For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.

Secondary Outcomes

  • Change in Six Minute Walk Test Distance(Prior to and after 8 week intervention.)
  • Change in 10 meter walk test(Prior to and after 8 week intervention.)
  • Change in Self Efficacy for Exercise Scale score(Prior to and after 8 week intervention.)
  • Change in Parkinson Disease Questionnaire-39 score(Prior to and after 8 week intervention.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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