Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease

The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Physiotherapy Interventions; Other: Education Classes

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
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Queen Elizabeth Hospital
    • Contact: CW Woo; Phone Number: 29586218; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: Education	Other: Education Classes; Education Classes; Other Names: Education

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test		Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
Activities-Specific Balance Confidence Scale (Chinese version)		Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention
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
Number of Injurious Falls		Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention

Collaborators and Investigators

• Sponsor: Queen Elizabeth Hospital, Hong Kong
• Investigators: Principal Investigator: CW WOO, Physiotherapy Department, Queen Elizabeth Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2010
• Last Update Submitted That Met QC Criteria: March 9, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: KCKESOP0016a