Freezing of Gait in Parkinson's Disease (FOG)

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Duke University

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: Placebo group - non use of Tower of Hanoi
Device: Tower of Hanoi

Study type

Interventional

Funder types

Other

Identifiers

NCT01887054
Pro00045495

Details and patient eligibility

About

This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.

Full description

This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG). This study will involve 2 study groups: Group A - training group; Group B - no training group/controls. Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks. Participation in this study is expected to last 6-8 weeks.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: greater than 18 years old and without an upper age limit
  • diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
  • Ambulate independently without an assistive device for at least 60 meters
  • Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
  • Willingness and ability to participate in training and complete training diary
  • Documented FOG-Q and Unified Parkinson's Disease Rating Scale (UPDRS) II
  • Ability to sign informed consent
  • Pregnant females will be included in the study and there are no known risks to the pregnant female or fetus

Exclusion criteria

  • Inability to complete questionnaires
  • Unwillingness to participate in training, complete all questionnaires and training diary
  • Subjects with secondary causes of parkinsonism
  • Significant dementia (MOCA <20)
  • Prior deep brain stimulation (DBS) surgery or pallidotomy
  • Subjects cannot participate in any form of Physical Therapy, Occupational Therapy or Speech Therapy during the study period
  • Subjects cannot start any new medications during the study period.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups, including a placebo group

Training Group
Active Comparator group
Description:
There are 2 study visits. Subjects in this group will complete the following: Visit 1 Gait evaluation Neuropsychological testing Questionnaires and assessments Taught how to complete a visual problem-solving task (Tower of Hanoi) Given a diary to record training at home. In-home •For 6 weeks at home, complete the in-home visual problem-solving tasks as instructed at Visit 1 Visit 2 Gait evaluation Neuropsychological testing Questionnaires and assessments
Treatment:
Device: Tower of Hanoi
Non Training Group
Placebo Comparator group
Description:
There are 2 study visits. Subjects in this group will complete the following: Visit 1 Gait evaluation Neuropsychological testing Questionnaires and assessments Visit 2 Gait evaluation Neuropsychological testing Questionnaires and assessments
Treatment:
Other: Placebo group - non use of Tower of Hanoi

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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