Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Acupuncture,Intracerebral hemorrhage, Stroke
Eligibility Criteria
Patient inclusion Criteria:
- Patients after acute hemorrhagic stroke;
- Within the first month after acute presentation;
- Premorbid mobility level: Independent Indoor or Outdoor Walker;
- Co-operative and willing to comply with the rehabilitation program;
Patient exclusion Criteria:
- Cardiac Pacemaker;
- Patient who is apprehensive to acupuncture;
- Clotting abnormality;
- Poor local skin conditions.
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture
Control
Arm Description
Acupuncture and conventional rehabilitation
Conventional rehabilitation only
Outcomes
Primary Outcome Measures
Glasgow Outcome Scale Extended
Secondary Outcome Measures
Functional Independence Measure (FIM) score
Modified Aschoff Score
Neurocognitive State Examination(NCSE)score
Motor scores of upper limb and lower limb with Fugl-Meyer Scale
Modified Functional Ambulation Category (MFAC)
Modified Rivermead Mobility Index (MRMI)
Barthel Index
Modified Rankin Scale
Full Information
NCT ID
NCT01037894
First Posted
December 22, 2009
Last Updated
January 10, 2013
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01037894
Brief Title
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Official Title
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acupuncture,Intracerebral hemorrhage, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture and conventional rehabilitation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation only
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.
Intervention Type
Procedure
Intervention Name(s)
Conventional rehabilitation
Intervention Description
In-patient physiotherapy, occupational therapy and speech therapy.
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale Extended
Time Frame
Six week
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM) score
Time Frame
Six week
Title
Modified Aschoff Score
Time Frame
Six week
Title
Neurocognitive State Examination(NCSE)score
Time Frame
Six week
Title
Motor scores of upper limb and lower limb with Fugl-Meyer Scale
Time Frame
six week
Title
Modified Functional Ambulation Category (MFAC)
Time Frame
Six week
Title
Modified Rivermead Mobility Index (MRMI)
Time Frame
Six week
Title
Barthel Index
Time Frame
Six week
Title
Modified Rankin Scale
Time Frame
Six week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient inclusion Criteria:
Patients after acute hemorrhagic stroke;
Within the first month after acute presentation;
Premorbid mobility level: Independent Indoor or Outdoor Walker;
Co-operative and willing to comply with the rehabilitation program;
Patient exclusion Criteria:
Cardiac Pacemaker;
Patient who is apprehensive to acupuncture;
Clotting abnormality;
Poor local skin conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George KC Wong
Organizational Affiliation
Division of Neurosurgery, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
852
Country
China
12. IPD Sharing Statement
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Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
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