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

NCT ID: NCT05625789

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2024-08-09

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Postural control (weight shifting) training followed by steady state gait training.

For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions.

To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training.

Each training will be three times per week for two weeks. There is a one week break between the two trainings.

Group Type: EXPERIMENTAL

Postural control (weight shift) training

Intervention Type: BEHAVIORAL

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

Steady state gait training

Intervention Type: 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.

Steady state gait training followed by postural control (weight shifting) training.

To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training.

For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions.

Each training will be three times per week for two weeks. There is a one week break between the two trainings.

Group Type: EXPERIMENTAL

Postural control (weight shift) training

Intervention Type: BEHAVIORAL

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

Steady state gait training

Intervention Type: 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.

Interventions

Postural control (weight shift) training

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

Intervention Type: BEHAVIORAL

Steady state gait training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LSVT Global

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lewek, PhD

Role: STUDY_DIRECTOR

UNC Chapel Hill

Chelsea P Duppen, DPT

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

22-2628

Identifier Type: -

Identifier Source: org_study_id