Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04897256

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in variability in number of steps to complete a turn

    Time frame: 6 weeks

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

Secondary outcomes

  1. Change in Falls Efficacy Scale International

    Time frame: 6 weeks

    A 16 item self-administered questionnaire to assess fear of falling. Score range 16-64 with higher score indicating more fear of falling

  2. Change in prospective fall rate

    Time frame: 52 weeks

    Number of prospective falls recorded for 12 months starting from the end of intervention

  3. Change in patient global impression of change

    Time frame: 6 weeks

    Question of participant's rating of mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility

  4. Change in number of steps to complete a turn

    Time frame: 6 weeks

    Number of steps in a turning averaged from daily monitoring

  5. Change in turn peak velocity

    Time frame: 6 weeks

    Peak velocity of turns averaged from daily monitoring

  6. Change in turn angle amplitude

    Time frame: 6 weeks

    Peak size of turn angles averaged from daily monitoring

  7. Change in turn duration

    Time frame: 6 weeks

    Time to complete turns averaged from daily monitoring

  8. Change in turn trunk jerk

    Time frame: 6 weeks

    A measure of smoothness of turning; the rate of change of acceleration during a turn averaged from daily monitoring

  9. Change in variability of double-support time

    Time frame: 6 weeks

    Coefficient of variation in time of double-support phase

  10. Change in lateral trunk range

    Time frame: 6 weeks

    range of motion in the trunk during walking, in the lateral direction

Other outcomes

  1. Change in mini-Balance Evaluation Systems Test

    Time frame: 6 weeks

    Clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait. Scores range from 0-28 with higher scores indicating worse balance

  2. Change in clinical global impression of change

    Time frame: 6 weeks

    Question of clinician's rating of participant mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility.

  3. Change in Parkinson's Disease Questionnaire-39

    Time frame: 6 weeks

    A 39 item self-report questionnaire to assess Parkinson's disease specific health related quality in eight domains of quality of life. Each item scores from 0 (never) to 4 (always). Sub-scale scores and a Parkinson's Disease summary index (PDSI; sum of eight subsections/8) representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life

  4. Change in Unified Parkinson's Disease Rating Scale, Part III

    Time frame: 6 weeks

    A clinical scale to assess severity of motor symptoms in Parkinson's disease. Each item is scored 0 (normal) to 4 (severe) with a score range from 0-132

  5. Change in Activities-Specific Balance Confidence Scale

    Time frame: 6 weeks

    A 16-item self-report scale that participants rate their confidence in performing daily activities. Score range from 0-100% with 0% meaning no confidence and 100% completely confident

  6. Change in stride velocity

    Time frame: 6 weeks

    Stride velocity during straight walking averaged from daily monitoring

  7. Change in stride length

    Time frame: 6 weeks

    Stride length during straight walking averaged from daily monitoring

  8. Change in cadence

    Time frame: 6 weeks

    The number of straight walking steps taken per minute averaged from daily monitoring

  9. Change in double support time

    Time frame: 6 weeks

    The amount of time both feet were on the ground together during straight walking averaged from daily monitoring

  10. Change in angle of foot at heel strike

    Time frame: 6 weeks

    The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring

  11. Change in variability of angle of foot at heel strike

    Time frame: 6 weeks

    Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring

  12. Change in number of turns per hour

    Time frame: 6 weeks

    The average number of turns per hour measured during daily monitoring

  13. Change in number of bouts of walking and steps per day

    Time frame: 6 weeks

    The average number of walking bouts and number of steps per day, measured during daily monitoring

  14. Change in duration of longest walking bout per day

    Time frame: 6 weeks

    The longest bout of straight walking per day averaged from daily monitoring

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 21, 2021
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.