Effectiveness of Physiotherapy Interventions for Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01076712
• Other study ID #: KCKESOP0016a
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2010
• Last updated: March 9, 2010
• Start date: March 2010
• Est. completion date: October 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Physiotherapy Interventions
Physiotherapy interventions including strengthening exercise, balance training, gait training with visual cus and gait training with treadmill
• Education Classes
Education Classes

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (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, — 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

Outcome

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