Parkinson Disease Clinical Trial
Official title:
The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial
Verified date | March 2010 |
Source | Queen Elizabeth Hospital, Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Ethics Committee |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 112 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Elizabeth Hospital | Kowloon |
Lead Sponsor | Collaborator |
---|---|
Queen Elizabeth Hospital, Hong Kong |
Hong Kong,
Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, — View Citation
Herman T, Giladi N, Gruendlinger L, Hausdorff JM. Six weeks of intensive treadmill training improves gait and quality of life in patients with Parkinson's disease: a pilot study. Arch Phys Med Rehabil. 2007 Sep;88(9):1154-8. — View Citation
Hirsch MA, Toole T, Maitland CG, Rider RA. The effects of balance training and high-intensity resistance training on persons with idiopathic Parkinson's disease. Arch Phys Med Rehabil. 2003 Aug;84(8):1109-17. — View Citation
Mak MK, Lau AL, Law FS, Cheung CC, Wong IS. Validation of the Chinese translated Activities-Specific Balance Confidence scale. Arch Phys Med Rehabil. 2007 Apr;88(4):496-503. — View Citation
Morris S, Morris ME, Iansek R. Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease. Phys Ther. 2001 Feb;81(2):810-8. — View Citation
Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I. Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. Erratum in: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126. — View Citation
Tsang KL, Chi I, Ho SL, Lou VW, Lee TM, Chu LW. Translation and validation of the standard Chinese version of PDQ-39: a quality-of-life measure for patients with Parkinson's disease. Mov Disord. 2002 Sep;17(5):1036-40. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale | Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention | No | |
Primary | Levodopa equivalent daily dosage (LEDD) | Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention | No | |
Secondary | Timed Up and Go Test | Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention | No | |
Secondary | Activities-Specific Balance Confidence Scale (Chinese version) | Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention | No | |
Secondary | Parkinson's Disease Questionnaire (Standard Chinese Version) | Parkinson's Disease Questionnaire (Standard Chinese Version) - PDQ-39 (Chinese) | Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention | No |
Secondary | Number of Injurious Falls | Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention | No |
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