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Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

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ClinicalTrials.gov Identifier: NCT01037894
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong

December 22, 2009
December 23, 2009
January 14, 2013
January 2009
September 2012   (Final data collection date for primary outcome measure)
Glasgow Outcome Scale Extended [ Time Frame: Six week ]
Same as current
Complete list of historical versions of study NCT01037894 on ClinicalTrials.gov Archive Site
  • Functional Independence Measure (FIM) score [ Time Frame: Six week ]
  • Modified Aschoff Score [ Time Frame: Six week ]
  • Neurocognitive State Examination(NCSE)score [ Time Frame: Six week ]
  • Motor scores of upper limb and lower limb with Fugl-Meyer Scale [ Time Frame: six week ]
  • Modified Functional Ambulation Category (MFAC) [ Time Frame: Six week ]
  • Modified Rivermead Mobility Index (MRMI) [ Time Frame: Six week ]
  • Barthel Index [ Time Frame: Six week ]
  • Modified Rankin Scale [ Time Frame: Six week ]
  • FIM score [ Time Frame: Six week ]
  • Modified Aschoff Score [ Time Frame: Six week ]
  • NCSE score [ Time Frame: Six week ]
  • Motor scores of upper limb and lower limb with Fugl-Meyer Scale [ Time Frame: six week ]
  • Modified Functional Ambulation Category (MFAC) [ Time Frame: Six week ]
  • Modified Rivermead Mobility Index (MRMI) [ Time Frame: Six week ]
  • Barthel Index [ Time Frame: Six week ]
  • Modified Rankin Scale [ Time Frame: Six week ]
Not Provided
Not Provided
 
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
The purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.

The investigators aim to recruit 60 patients over a 30 month period. Each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome).

Primary outcome measures:

Clinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.

Secondary outcome measures:

Modified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score, Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stroke
  • Procedure: Acupuncture
    Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.
  • Procedure: Conventional rehabilitation
    In-patient physiotherapy, occupational therapy and speech therapy.
  • Experimental: Acupuncture
    Acupuncture and conventional rehabilitation
    Intervention: Procedure: Acupuncture
  • Active Comparator: Control
    Conventional rehabilitation only
    Intervention: Procedure: Conventional rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
60
September 2012
September 2012   (Final data collection date for primary outcome measure)

Patient inclusion Criteria:

  1. Patients after acute hemorrhagic stroke;
  2. Within the first month after acute presentation;
  3. Premorbid mobility level: Independent Indoor or Outdoor Walker;
  4. Co-operative and willing to comply with the rehabilitation program;

Patient exclusion Criteria:

  1. Cardiac Pacemaker;
  2. Patient who is apprehensive to acupuncture;
  3. Clotting abnormality;
  4. Poor local skin conditions.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01037894
GW003
Yes
Not Provided
Not Provided
George KC Wong, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: George KC Wong Division of Neurosurgery, CUHK
Chinese University of Hong Kong
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP