Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

The Chinese University of Hong Kong

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke

Treatments: Procedure: Conventional rehabilitation; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01037894

GW003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Acupuncture and conventional rehabilitation

Treatment:

Procedure: Acupuncture

Control

Active Comparator group

Description:

Conventional rehabilitation only

Treatment:

Procedure: Conventional rehabilitation