Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation

NCT04897256 | Active Not Recruiting

• 1 other identifier: R01HD100383
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in variability in number of steps to complete a turn

  Coefficient of variation in the number of steps in a turn, averaged from daily monitoring

  6 weeks

Secondary Outcomes (10)

• Change in Falls Efficacy Scale International

  6 weeks

• Change in prospective fall rate

  52 weeks

• Change in patient global impression of change

  6 weeks

• Change in number of steps to complete a turn

  6 weeks

• Change in turn peak velocity

  6 weeks

Other Outcomes (14)

• Change in mini-Balance Evaluation Systems Test

  6 weeks

• Change in clinical global impression of change

  6 weeks

• Change in Parkinson's Disease Questionnaire-39

  6 weeks

Study Arms (2)

TURN-IT group

EXPERIMENTAL

Participants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator.

Behavioral: TURN-IT exercise program

No Intervention Control Group

NO INTERVENTION

Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period.

Interventions

TURN-IT exercise program BEHAVIORAL

Based on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focuses on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting and increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging (such as adding a dual task). Initially participants will be supported in an overhead body-weight support system (ZeroG) to allow them to practice challenging exercises without the risk of falling.

TURN-IT group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
• Responsive to levodopa
• Hoehn \& Yahr stages II-IV
• Age range 55-85 years old
• self-report of one or more falls in past 12 months
• willing and able to attend exercise intervention sessions at OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels.

You may not qualify if:

• Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
• no medical condition that precludes exercise
• MoCA ≤ 21 or inability to follow directions
• excessive use of alcohol or recreational drugs
• recent change in medication
• inability to stand and walk for 2 minutes without an assistive device

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• King LA, Carlson-Kuhta P, Wilhelm JL, Lapidus JA, Dale ML, Talman LS, Barlow N, Mancini M, Horak FB. TURN-IT: a novel turning intervention program to improve quality of turning in daily life in people with Parkinson's disease. BMC Neurol. 2022 Nov 28;22(1):442. doi: 10.1186/s12883-022-02934-5.

  PMID: 36443737 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Fay Horak, PhD, PT

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators involved in measuring outcomes and analyzing the data, will remain blinded to the group that participants are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: September 13, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.
• Access Criteria: Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.

Locations

US (1)