Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

January 10, 2013 updated by: George KC Wong, Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 852
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Active Comparator: Control
Conventional rehabilitation only
Procedure: Conventional rehabilitation
In-patient physiotherapy, occupational therapy and speech therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glasgow Outcome Scale Extended
Time Frame: Six week
Six week

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional Independence Measure (FIM) score
Time Frame: Six week
Six week
Modified Aschoff Score
Time Frame: Six week
Six week
Neurocognitive State Examination(NCSE)score
Time Frame: Six week
Six week
Motor scores of upper limb and lower limb with Fugl-Meyer Scale
Time Frame: six week
six week
Modified Functional Ambulation Category (MFAC)
Time Frame: Six week
Six week
Modified Rivermead Mobility Index (MRMI)
Time Frame: Six week
Six week
Barthel Index
Time Frame: Six week
Six week
Modified Rankin Scale
Time Frame: Six week
Six week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: George KC Wong, Division of Neurosurgery, CUHK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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