Recruiting

Agility & Strength

Sponsor:

Oregon Health and Science University

Code:

NCT06815302

Conditions

Parkinson Disease

Freezing of Gait Symptoms in Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Experimental intervention

Active intervention

Study Details

Brief summary:

The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.

Participants will:

  • Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)
  • Have one-on-one training sessions three times per week for 6 weeks
  • Perform in-lab assessments before beginning and after completing the study intervention
  • Use wearable mobility sensors during daily life to measure their walking and balance

Conditions

Parkinson Disease

Freezing of Gait Symptoms in Parkinson Disease

Study ID

NCT06815302

Start date

Jun 2, 2025

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
  • reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)
  • Hoehn \& Yahr stages II-IV
  • ages 50-80 years old
  • cognitive ability sufficient to participate in testing procedures and exercise classes
  • be willing and able to participate in exercise intervention 3x/week for 6 weeks

Exclusion Criteria:

  • Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease)
  • medical condition or medications that precludes moderate-intensity exercise
  • Montreal Cognitive Assessment (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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dynamic balance exercise intervention group

Six weeks of exercise intervention to improve gait disturbances.

Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

active comparator: Strength training exercise intervention group

Six weeks of exercise intervention to improve gait disturbances.

Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Interventions

Experimental intervention

Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Active intervention

Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Primary outcome measure

  • Patient- Perceived Freezing of Gait Severity [ Time Frame: From enrollment/randomization through intervention; 8 weeks ]
  • Clinician- Perceived Freezing of Gait Severity [ Time Frame: From enrollment/randomization through intervention; 8 weeks ]
  • Sensors-based Freezing of gait severity [ Time Frame: From enrollment/randomization through intervention; 8 weeks ]

Central Contacts and Locations

Central contacts

Graham R Harker, MPH

(503) 418-2601harkerg@ohsu.edu

Locations

Arizona State University

Recruiting

Tempe, Arizona, United States, 85281

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-07-28.