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Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01076712
Recruitment Status : Unknown
Verified March 2010 by Queen Elizabeth Hospital, Hong Kong.
Recruitment status was:  Recruiting
First Posted : February 26, 2010
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
Queen Elizabeth Hospital, Hong Kong

Brief Summary:
Parkinson's Disease is an incurable and progressive disease. Treatment includes medication and non-pharmacological intervention such as physiotherapy. Physiotherapy is a main component of non-pharmacological interventions. It includes exercise to strengthen the muscles; improves balance and walking, and adopts the use of visual cue training. Treatment has been found to be effective in patients with mild impairment up to 6 months post-treatment. The present study will investigate the effectiveness of treatment for patients with mild to moderate impairment for short term (3-month) and long term (1 year). The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Physiotherapy Interventions Other: Education Classes Not Applicable

Detailed Description:
Parkinson's disease (PD) is an incurable and progressive disease (Rubenis 2007). Current management include medical, neuro-surgical and non-pharmacological intervention. Physiotherapy is a major component in non-pharmacological interventions. Effective interventions including visual or auditory cues improves gait (Nieuwboer et al. 2007), exercise is effective in improving balance (Hirsch et al 2003); intense treadmill training improves motor control, quality of life and walking speed so as to sustain improvement in gait speed and motor control post 4 weeks of treatment (Herman et al 2007). Patient with PD attending physiotherapy twice weekly, one and half hour for 12 weeks showed improvement in walking speed and Activities of Daily Living (Ellis et al 2005). However, the majority of focus on patients in the Hoehn and Yahr stage of 2 to 3 and long term effect is lacking (Kwakkel et al 2007). A knowledge gap is present in the effectiveness of physiotherapy training of patients with Parkinson's disease in the more advanced stage of disease and long term effect is lacking. The aim of the study is to investigate the immediate, short-term & long-term clinical effects of physiotherapy training of patients with Parkinson's disease. The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial
Study Start Date : March 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Physiotherapy Interventions
Physiotherapy Interventions including strengthening exercise, balance training, gait training with visual cue, gait training with treadmill.
Other: Physiotherapy Interventions
Physiotherapy interventions including strengthening exercise, balance training, gait training with visual cus and gait training with treadmill
Education
Education
Other: Education Classes
Education Classes
Other Name: Education



Primary Outcome Measures :
  1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ]
  2. Levodopa equivalent daily dosage (LEDD) [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ]

Secondary Outcome Measures :
  1. Timed Up and Go Test [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ]
  2. Activities-Specific Balance Confidence Scale (Chinese version) [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ]
  3. Parkinson's Disease Questionnaire (Standard Chinese Version) [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ]
    Parkinson's Disease Questionnaire (Standard Chinese Version) - PDQ-39 (Chinese)

  4. Number of Injurious Falls [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable medication usage
  • Hoehn and Yahr stage II to IV
  • At least 1 score of 2 or more for at least 1 limb of either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Able to walk independently
  • No severe cognitive impairments (Mini-Mental State Examination - Chinese Cantonese version) score greater than 24

Exclusion Criteria:

  • Other severe neurological, cardiopulmonary, or orthopedic disorders
  • Having participated in a physiotherapy or rehabilitation program in previous 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076712


Locations
Hong Kong
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong
Contact: CW Woo    29586218    woocw@ha.org.hk   
Sub-Investigator: YF Cheung, Dr         
Sub-Investigator: HF Chan, Dr         
Sub-Investigator: HM Chan, Dr         
Sub-Investigator: MY Lau, Dr         
Sub-Investigator: HS Chan         
Sub-Investigator: HF Mak         
Sponsors and Collaborators
Queen Elizabeth Hospital, Hong Kong
Investigators
Principal Investigator: CW WOO Physiotherapy Department, Queen Elizabeth Hospital

Publications of Results:
Other Publications:
Responsible Party: WOO Cheuk Wai, Physiotherapy Department, Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT01076712     History of Changes
Other Study ID Numbers: KCKESOP0016a
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases