Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Physiotherapy Interventions
Education Classes
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
- Queen Elizabeth HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Physiotherapy Interventions
Education
Arm Description
Physiotherapy Interventions including strengthening exercise, balance training, gait training with visual cue, gait training with treadmill.
Education
Outcomes
Primary Outcome Measures
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Levodopa equivalent daily dosage (LEDD)
Secondary Outcome Measures
Timed Up and Go Test
Activities-Specific Balance Confidence Scale (Chinese version)
Parkinson's Disease Questionnaire (Standard Chinese Version)
Parkinson's Disease Questionnaire (Standard Chinese Version) - PDQ-39 (Chinese)
Number of Injurious Falls
Full Information
NCT ID
NCT01076712
First Posted
February 25, 2010
Last Updated
March 9, 2010
Sponsor
Queen Elizabeth Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01076712
Brief Title
Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease
Official Title
The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Queen Elizabeth Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy Interventions
Arm Type
Experimental
Arm Description
Physiotherapy Interventions including strengthening exercise, balance training, gait training with visual cue, gait training with treadmill.
Arm Title
Education
Arm Type
Other
Arm Description
Education
Intervention Type
Other
Intervention Name(s)
Physiotherapy Interventions
Intervention Description
Physiotherapy interventions including strengthening exercise, balance training, gait training with visual cus and gait training with treadmill
Intervention Type
Other
Intervention Name(s)
Education Classes
Other Intervention Name(s)
Education
Intervention Description
Education Classes
Primary Outcome Measure Information:
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Time Frame
Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
Title
Levodopa equivalent daily dosage (LEDD)
Time Frame
Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
Secondary Outcome Measure Information:
Title
Timed Up and Go Test
Time Frame
Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
Title
Activities-Specific Balance Confidence Scale (Chinese version)
Time Frame
Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
Title
Parkinson's Disease Questionnaire (Standard Chinese Version)
Description
Parkinson's Disease Questionnaire (Standard Chinese Version) - PDQ-39 (Chinese)
Time Frame
Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
Title
Number of Injurious Falls
Time Frame
Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CW WOO
Organizational Affiliation
Physiotherapy Department, Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CW Woo
Phone
29586218
Email
woocw@ha.org.hk
First Name & Middle Initial & Last Name & Degree
YF Cheung, Dr
First Name & Middle Initial & Last Name & Degree
HF Chan, Dr
First Name & Middle Initial & Last Name & Degree
HM Chan, Dr
First Name & Middle Initial & Last Name & Degree
MY Lau, Dr
First Name & Middle Initial & Last Name & Degree
HS Chan
First Name & Middle Initial & Last Name & Degree
HF Mak
12. IPD Sharing Statement
Citations:
PubMed Identifier
17229744
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. doi: 10.1136/jnnp.200X.097923. Erratum In: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126.
Results Reference
background
PubMed Identifier
12917847
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. doi: 10.1016/s0003-9993(03)00046-7.
Results Reference
background
PubMed Identifier
17826461
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. doi: 10.1016/j.apmr.2007.05.015.
Results Reference
background
PubMed Identifier
19025984
Citation
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, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
Results Reference
result
PubMed Identifier
11175678
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. doi: 10.1093/ptj/81.2.810.
Results Reference
result
PubMed Identifier
17398252
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. doi: 10.1016/j.apmr.2007.01.018.
Results Reference
result
PubMed Identifier
12360555
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. doi: 10.1002/mds.10249.
Results Reference
result
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Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease
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