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

NCT ID: NCT04897256

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TURN-IT group

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.

Group Type: EXPERIMENTAL

TURN-IT exercise program

Intervention Type: 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.

No Intervention Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TURN-IT exercise program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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

2. Responsive to levodopa

3. Hoehn & Yahr stages II-IV

4. Age range 55-85 years old

5. self-report of one or more falls in past 12 months

6. willing and able to attend exercise intervention sessions at OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels.

Exclusion Criteria

1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD

2. no medical condition that precludes exercise

3. MoCA ≤ 21 or inability to follow directions

4. excessive use of alcohol or recreational drugs

5. recent change in medication

6. inability to stand and walk for 2 minutes without an assistive device

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Martina Mancini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fay Horak, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36443737 (View on PubMed)

Other Identifiers

R01HD100383

Identifier Type: NIH

Identifier Source: secondary_id

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R01HD100383

Identifier Type: NIH

Identifier Source: org_study_id

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