Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

NCT ID: NCT01037894

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

Acupuncture and conventional rehabilitation

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.

Control

Conventional rehabilitation only

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type PROCEDURE

In-patient physiotherapy, occupational therapy and speech therapy.

Interventions

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Acupuncture

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

Conventional rehabilitation

In-patient physiotherapy, occupational therapy and speech therapy.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Exclusion Criteria

1. Cardiac Pacemaker;
2. Patient who is apprehensive to acupuncture;
3. Clotting abnormality;
4. Poor local skin conditions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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George KC Wong

Professor (Clinical)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George KC Wong

Role: PRINCIPAL_INVESTIGATOR

Division of Neurosurgery, CUHK

Locations

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Prince of Wales Hospital

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Other Identifiers

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GW003

Identifier Type: -

Identifier Source: org_study_id

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