Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease - Full Text View

Purpose

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	Intervention
Parkinson Disease	Other: Physiotherapy Interventions Other: Education Classes

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Exercise and Physical Fitness Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Queen Elizabeth Hospital, Hong Kong:

Primary Outcome Measures:

Movement Disorder Society-Unified Parkinson's Disease Rating Scale [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ] [ Designated as safety issue: No ]
Levodopa equivalent daily dosage (LEDD) [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Timed Up and Go Test [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ] [ Designated as safety issue: No ]
Activities-Specific Balance Confidence Scale (Chinese version) [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ] [ Designated as safety issue: No ]
Parkinson's Disease Questionnaire (Standard Chinese Version) [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ] [ Designated as safety issue: No ]
Parkinson's Disease Questionnaire (Standard Chinese Version) - PDQ-39 (Chinese)
Number of Injurious Falls [ Time Frame: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	112
Study Start Date:	March 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: Physiotherapy Interventions
Education Education	Other: Education Classes Education Classes Other Name: Education

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.

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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.

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.

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.

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.

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 Jan;81(1):126.

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.

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.

Responsible Party:	WOO Cheuk Wai, Physiotherapy Department, Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:	NCT01076712 History of Changes
Other Study ID Numbers:	KCKESOP0016a
Study First Received:	February 25, 2010
Last Updated:	March 9, 2010
Health Authority:	Hong Kong: Ethics Committee

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 18, 2013