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Completed

NCT Number: NCT05625789

How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease

The purpose of this study is to understand the treatment approach (i.e., targeting gait or targeting the postural adjustment prior to gait) that is most effective at improving gait initiation dynamics in people with Parkinson disease. Ten adults with idiopathic Parkinson disease who self-report difficulty initiating gait will complete the study. The investigators will be using a randomized crossover design, where the participants will participate in two series of training (i.e., postural training and steady-state gait training) with a one-week washout between trainings. Investigators will evaluate the changes induced in gait initiation postural adjustment size, first step length, and first step speed from each intervention. Due to the anticipated limitation of steady-state walking to directly address postural adjustment amplitude, it is hypothesized that training for larger amplitude weight shift during gait initiation will yield improved gait initiation dynamics compared to training with large amplitude movements during steady-state walking.

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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

35 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, 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 Parkinson disease characterized by asymmetrical onset of at least 2 of 3 cardinal signs (resting tremor, bradykinesia, or rigidity) with no atypical signs or exposure to dopamine-blocking drugs
  • The presence of mild to moderate gait or balance impairment (a rating of 1-2 on MDS Unified Parkinson Disease Rating Scale (MDS-UPDRS) item 10 [gait] or rating 1-3 on item 12 [postural stability]
  • Hoehn & Yahr stages 1-3 ("on" for those who fluctuate)
  • Self-report of difficulty with freezing of gait (i.e., a rating of 1-4 on question 3 of the Freezing of Gait Questionnaire)
  • All participants must be able to walk > 5 minutes at greater than or equal to 80% of comfortable gait speed (CGS) on the treadmill and > 5 minutes over ground without assistance or an assistive device.

Exclusion criteria

  • Uncontrolled cardiorespiratory/metabolic disease, vestibular dysfunction that may affect gait or balance
  • Parkinson's related or unrelated dementia (i.e. Montreal Cognitive Assessment score <21)
  • Comfortable over ground walking speed of less than 0.5m/s
  • History of traumatic brain injury
  • self-reported deafness or blindness as this would impair the patient's ability to hear cues or ambulate safely within the lab environment
  • other neurological disorders or orthopedic injury that may affect gait
  • recent orthopedic surgery (in the last 6 months)
  • Participants will also be excluded if they have severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures
  • Participants who are currently receiving supervised physical therapy services

Treatment and study plan

Postural control (weight shift) training

Behavioral

Visual cues to improve amplitude of weight shift prior to initiating gait.

Steady state gait training

Behavioral

Auditory cues are provided to increase amplitude of movement (e.g., step length) during continuous walking, to determine its effects on gait initiation amplitude of movement.

Primary outcomes

  1. Change in First Step Length from Baseline to Conclusion of the first block of training

    Time frame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)

    Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).

  2. Change in First Step Length from end of first block of training to training 2 pre-test

    Time frame: Conclusion of first training block, just prior to beginning the second training series (1 week)

    Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).

  3. Change in First Step Length from training block 2 pre-test to conclusion of second block of training

    Time frame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)

    Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).

  4. Change in First Step Length from conclusion of second training block to 1 week follow up from second training block

    Time frame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)

    Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).

Secondary outcomes

  1. Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from Baseline to Conclusion of the first block of training

    Time frame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)

    Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).

  2. Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from end of first block of training to training 2 pre-test

    Time frame: Conclusion of first training block, just prior to beginning the second training series (1 week)

    Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).

  3. Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from training block 2 pre-test to conclusion of second block of training

    Time frame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)

    Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).

  4. Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from conclusion of second training block to 1 week follow up from second training block

    Time frame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)

    Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).

  5. Change in First Step Speed from Baseline to Conclusion of the first block of training

    Time frame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)

    First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.

  6. Change in First Step Speed from end of first block of training to training 2 pre-test

    Time frame: Conclusion of first training block, just prior to beginning the second training series (1 week)

    First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.

  7. Change in First Step Speed from training block 2 pre-test to conclusion of second block of training

    Time frame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)

    First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.

  8. Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block

    Time frame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)

    First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • LSVT Global

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 23, 2022
Registry last updated
Sep 20, 2024

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.

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