Multiple Practice Contexts to Reduce Context-dependent Learning in PD

NCT03368443 | Completed

• 1 other identifier: 201612139RIND
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Context-dependent learning (CDL) is a phenomenon that an individual demonstrates superior motor performance in the environmental context in which a task was originally learned and practiced, while the performance may decrease if carried out in a novel context. It has often been observed that after individuals with Parkinson's disease (PD) learned how to walk in a clinical setting, they appear to have difficulty generalizing the learned walking ability back to their home or community. To date, no effective intervention approaches have been designed to resolve this CDL for people with PD. One approach that could potentially reduce CDL is to practice a motor task in multiple contexts. Learning a task in multiple contexts would make the participants less likely to rely on the inconsistent ambient contextual information, and could facilitate the generation of stronger motor program and schema. No studies to date have investigated the effects of multiple practice contexts on reducing CDL in people with PD. It is also not clear the characteristics of the participants who would benefit from this type of intervention. This study aims to investigate the effects of gait training in multiple practice contexts on CDL in individuals with PD. Additionally, this study aims to identify the characteristics of the participants who benefit from the intervention. Sixty-four participants diagnosed with idiopathic PD will be recruited and randomized into 2 groups: Single-room and Two-room groups. The participants will receive 45 minutes of treadmill training and 15 minutes of over-ground gait training for 12 sessions. Throughout the training sessions, the Single-room group will practice walking in the same room, while the Two-room group will receive gait training in 2 distinct rooms. All participants will be assessed by a blinded evaluator before, immediately after, and 4 weeks after the intervention. The participants will undergo a series of cognitive, motor behavior, and neurophysiological examinations. Group × time repeated measures analysis of variance (ANOVA) and the partial eta square (η2) will be calculated to determine the intervention effects on the outcome measures. Multiple linear regression analyses will be performed to determine the demographic, cognitive and motor behavior, and neurophysiological characteristics of participants who benefit from the proposed interventions.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; context-dependent learning; transcranial magnetic stimulation; cognitive function

Outcome Measures

Primary Outcomes (5)

• Context-dependent learning

  To evaluate context-dependent learning, a finger sequence task has been specially designed. The participants will use an enlarged keyboard to complete the designed computer finger sequence task.

  45 mins

• 10-Meter Walk Test (10-MWT)

  The walking ability of the participants with PD will be assessed with the 10-MWT. The participants will be instructed to walk along a 10-meter walkway in their comfortable and fastest walking speed. Gait parameters including velocity, stride length, cadence, strike angle and lift-off angle will be calculated.

  5 mins

• The Timed Up and Go (TUG) Test

  The participants will initially sit on a comfortable chair with hips and knees flexed at 90°. Upon a 'GO' signal, the participants will stand up from the chair, walk for 3 meters, turn around, walk back to the chair, and sit down. The participants will be instructed to complete the task at their preferred/ comfortable speed. Good to excellent test-retest reliability and inter-rater reliability have been established in people with PD.

  5 mins

• Activities-Specific Balance Confidence (ABC) Scale

  The Activities-Specific Balance Confidence (ABC) scale will be used to examine an individual's confidence level of not falling when performing activities of daily living. The ABC Scale contains 16 different activities performed indoors and outdoors. The participants will be asked to rate their confidence level (range from 0% to 100% of confidence) of not falling for each item. An average score of the 16 items (range from 0% to 100%) will be calculated to determine the participant's confidence level of not falling when performing the activities of daily living. The internal consistency and test-retest reliability of the ABC scale in patients with PD were excellent.

  5 mins

• Corticomotor excitability

  Transcranial magnetic stimulation (TMS) will be used to evaluate corticomotor excitability. Corticomotor excitability outcomes will include resting motor threshold (RMT), motor evoke potential (MEP), cortical silent period (CSP) duration, short-interval intracortical inhibition (SICI), intracortical facilitation (ICF), and long-interval intracortical inhibition (LICI). The RMT could reflect the membrane excitability of the corticospinal neurons and the cortical interneurons. Peak-to-peak MEP amplitude is an indicator of the integrity and excitability of the corticospinal tract. The CSP is a period when EMG activity being suppressed for a few hundred milliseconds after the MEP, and has often been used as an indicator of the inhibitory mechanism occurs within the corticospinal tract. The SICI, ICF, and LICI have been identified to be good indicators of intracortical inhibition and facilitation.

  45 mins

Secondary Outcomes (6)

• Montreal Cognitive Assessment (MoCA)

  10 mins

• The Stroop Color-Word test

  5 mins

• The Unified Parkinson's Disease Rating Scale (UPDRS)

  10 mins

• Five Times Sit-to-Stand (FTSTS) Test

  5 mins

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  10 mins

Study Arms (2)

Single-room group

ACTIVE COMPARATOR

The participants assigned to the Single-room group will receive treadmill training and overground gait training in one room (Room A) throughout the training sessions.

Behavioral: treadmill training and overground gait training

Two-room group

EXPERIMENTAL

The participants in the Two-room group will receive treadmill training and overground gait training in 2 rooms (Room A and B) in an alternating order.

Behavioral: treadmill training and overground gait training

Interventions

treadmill training and overground gait training BEHAVIORAL

The participants will be randomized into two different groups, and they will receive treadmill and overground gait training in one or two rooms.

Single-room group; Two-room group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)
• able to read and hear properly without or with aids (e.g., eyeglasses or hearing aids)
• can walk independently with or without devices

You may not qualify if:

• has other neurological disorders in addition to PD
• has deep brain stimulation or pacemaker implanted in their body
• has a family-history of epilepsy
• has a self-history of seizure
• has unstable medical conditions

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

Related Publications (1)

• Lee YY, Tai CH, Fisher BE. Training in Varying Environmental Contexts Facilitates Transfer of Improved Gait Performance to New Contexts for Individuals With Parkinson Disease: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Oct;103(10):1917-1923. doi: 10.1016/j.apmr.2022.06.010. Epub 2022 Jul 8.

  PMID: 35810822 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ya-Yun Lee, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 11, 2017
• Study Start: December 25, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

TW (1)