NCT01076712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

Enrollment Period

2.6 years

First QC Date

February 25, 2010

Last Update Submit

March 9, 2010

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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)

    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

Study Arms (2)

Physiotherapy Interventions

EXPERIMENTAL

Physiotherapy Interventions including strengthening exercise, balance training, gait training with visual cue, gait training with treadmill.

Other: Physiotherapy Interventions

Education

OTHER

Education

Other: Education Classes

Interventions

Physiotherapy InterventionsOTHER

Physiotherapy interventions including strengthening exercise, balance training, gait training with visual cus and gait training with treadmill

Physiotherapy Interventions
Education ClassesOTHER

Education Classes

Also known as: Education
Education

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other severe neurological, cardiopulmonary, or orthopedic disorders
  • Having participated in a physiotherapy or rehabilitation program in previous 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Kowloon, Hong Kong

RECRUITING

Related Publications (9)

  • 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.

    PMID: 17229744BACKGROUND

  • 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.

    PMID: 12917847BACKGROUND

  • 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.

    PMID: 17826461BACKGROUND

  • 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.

    PMID: 19025984RESULT

  • 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.

    PMID: 11175678RESULT

  • 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.

    PMID: 17398252RESULT

  • 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.

    PMID: 12360555RESULT

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Prenatal EducationEducational Status

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • CW WOO

    Physiotherapy Department, Queen Elizabeth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

HK(1)