Balance Tele-Rehab in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorOregon Health and Science University
About this trial
This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
responsive to levodopa (self-reported)
Hoehn & Yahr stages I-III;
ages 55-85 years old
Disqualifiers
Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and balance (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease, etc.)
medical condition that precludes exercise
cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions
recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)
Trial design
Design model
Parallel
Treatments tested in this trial
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
Other interventionThe intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Supervised Tele-Rehabilitation Home ExerciseExperimental treatment 1 intervention
Group B: Unsupervised Rehabilitation Home ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation
The Mini-BESTest, a 14-item test of 4 domains of balance, that has been well studied and is related to fall risk in people with Parkinson's disease.
Time frame
Pre and Post rehabilitationSecondary outcomes
1
Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation
For the ISAW, the participant will don 3 sensors and be instructed to stand for 30 seconds, walk 12 steps, turn around, and walk back. The ISAW has the ability to characterize multiple domains of balance, similar to the Mini-BESTest, including postural sway in standing with feet together with eyes open for 30 seconds prior to step initiation and gait with a 180-degree turn. During the Modified ISAW, the participant will don 3 sensors and be instructed to stand for 30 seconds, walk at least 10 steps, turn 90 degrees and complete an L-shaped path, then turn 180 degrees and retrace the L-shaped path.
Time frame
Pre and Post rehabilitation2
Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation
The PGIC is one question rated on a seven point Likert scale measuring impression of change after intervention.
Time frame
after rehabilitation3
Parkinson's Disease Questionaire-39 (PDQ-39)
This is a questionnaire looking at how Parkinson's Disease has affected quality of life over the last month
Time frame
Pre and Post rehabilitation4
MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV
This is a questionnaire evaluating various aspects of Parkinson's disease, including motor and non-motor symptoms and activities of daily living.
Time frame
Pre and Post rehabilitationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov