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Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01037894
First received: December 22, 2009
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Stroke
 Procedure: Acupuncture
Procedure: Conventional rehabilitation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Glasgow Outcome Scale Extended [ Time Frame: Six week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Independence Measure (FIM) score [ Time Frame: Six week ] [ Designated as safety issue: No ]
  • Modified Aschoff Score [ Time Frame: Six week ] [ Designated as safety issue: No ]
  • Neurocognitive State Examination(NCSE)score [ Time Frame: Six week ] [ Designated as safety issue: No ]
  • Motor scores of upper limb and lower limb with Fugl-Meyer Scale [ Time Frame: six week ] [ Designated as safety issue: Yes ]
  • Modified Functional Ambulation Category (MFAC) [ Time Frame: Six week ] [ Designated as safety issue: No ]
  • Modified Rivermead Mobility Index (MRMI) [ Time Frame: Six week ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: Six week ] [ Designated as safety issue: Yes ]
  • Modified Rankin Scale [ Time Frame: Six week ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Acupuncture and conventional rehabilitation
 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.
Other Name: Acupuncture
Active Comparator: Control
Conventional rehabilitation only
 Procedure: Conventional rehabilitation
In-patient physiotherapy, occupational therapy and speech therapy.
Other Name: Conventional rehabilitation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037894

Locations
China, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong, China, 852
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: George KC Wong Division of Neurosurgery, CUHK
  More Information

No publications provided

Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01037894     History of Changes
Other Study ID Numbers: GW003
Study First Received: December 22, 2009
Last Updated: January 10, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Acupuncture,Intracerebral hemorrhage, Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013