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
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Procedure: Acupuncture Procedure: Conventional rehabilitation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Acupuncture and conventional rehabilitation
Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.
Active Comparator: Control
Conventional rehabilitation only
Procedure: Conventional rehabilitation
In-patient physiotherapy, occupational therapy and speech therapy.
- Glasgow Outcome Scale Extended [ Time Frame: Six week ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037894
|China, Hong Kong|
|Prince of Wales Hospital|
|Hong Kong, Hong Kong, China, 852|
|Principal Investigator:||George KC Wong||Division of Neurosurgery, CUHK|