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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03618901
Other study ID # MDRC2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2018
Est. completion date August 30, 2019

Study information

Verified date May 2019
Source Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.


Description:

Both interventions produce benefits to the PD population. PD SAFEx has been proven to improve the motor symptoms of PD. However, research still needs to be conducted on the PD specific benefits associated with RSB. As such it an RCT is necessary to compare the effects of both interventions.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 30, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- must be able to understand verbal instructions in English

- diagnosed with idiopathic PD by a neurologist

Exclusion Criteria:

- if diagnosed with a neurological condition other than PD

- if participated in an exercise program at least 2-weeks prior to the start of the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rock Steady Boxing
Boxing programs as offered by the Rock Steady Boxing institution,
PD SAFEx
Progressive proprioception training.

Locations

Country Name City State
Canada Movement Disorders Research and Rehabilitation Centre Waterloo Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Balance3 Balance will be measured using the mini- Balance Evaluation Systems Test (mini-best test). There are 4 sections: anticipatory, (sub score 6) reactive postural control (sub score 6), sensory orientation (sub score 6), dynamic gait (sub score 10). The total score that can be achieved is 28. The higher the score the better the balance. change from baseline at 12 weeks
Other Physical activity Community Healthy Activities Model Program for Seniors (CHAMPS) is a questionnaire used to assess the weekly frequency and duration of the physical activities of seniors. change from baseline at 12 weeks
Other Gait 2 For the 6-minute walking test (6MWT) participants will be asked to walk as far as possible for 6 minutes. The further (more laps) they are able to walk the better. change from baseline at 12 weeks
Primary Motor symptom improvements Unified Parkinson Disease Rating Scale (UPDRS) conducted by a qualified movement disorders specialist. The maximum score is 108, the higher the score, the worse the symptoms. change from baseline at 12 weeks
Secondary Quality of life assessments Completion of Parkinson's Disease Questionnaire (PDQ-39). There are 8 sections: mobility (sub score 10), activities of daily living (sub score 6), emotional well-being (sub score 6), stigma (sub score 4), social support (sub score 3), cognition (sub score 4), communication (sub score 3) and bodily discomfort (sub score 3). The higher the score, the worse the symptoms. change from baseline at 12 weeks
Secondary Balance1 Using the Biodex balance system. The postural stability test (PST) will be conducted. The results will be presented as actual score and standard deviation for both legs to determine an individuals ability to maintain balance. The lower the score the better. change from baseline at 12 weeks
Secondary Gait1 For the timed-up-and-go test (TUG) participants will stand up, walk to the line on the floor, turn around and walk back to the chair and sit down. change from baseline at 12 weeks
Secondary Strength Will be assessed using the Jamar hand dynamometer. change from baseline at 12 weeks
Secondary Cognitive Assessment 1 Scale of Outcomes of Parkinson Disease (SCOPA-COG), will be used to assess memory and visuospatial function. There are 5 sections: memory learning, attention, executive functions, visuo-spatial functions and memory. The total score that can be achieved is 43 (the higher the score the better). change from baseline at 12 weeks
Secondary cognitive assessment 3 Completion of Montreal Cognitive Assessment (MoCA). There are a total 30 points, the higher the score the better (26 and above is normal). change from baseline at 12 weeks
Secondary Balance 2 Activities-specific Balance Confidence Scale (ABC). The total score that can be achieved is 16, the higher the percent the more self-confidence. change from baseline at 12 weeks
Secondary Cognitive assessment 2 Mini-Mental State Examination (MMSE). The total score than can be achieved is otal score 30 (the higher the score the better). change from baseline at 12 weeks
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