NCT01037894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

December 22, 2009

Last Update Submit

January 10, 2013

Conditions

Stroke

Keywords

Acupuncture,Intracerebral hemorrhage, Stroke

Outcome Measures

Primary Outcomes (1)

  • Glasgow Outcome Scale Extended

    Six week

Secondary Outcomes (8)

  • Functional Independence Measure (FIM) score

    Six week

  • Modified Aschoff Score

    Six week

  • Neurocognitive State Examination(NCSE)score

    Six week

  • Motor scores of upper limb and lower limb with Fugl-Meyer Scale

    six week

  • Modified Functional Ambulation Category (MFAC)

    Six week

  • +3 more secondary outcomes

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture and conventional rehabilitation

Procedure: Acupuncture

Control

ACTIVE COMPARATOR

Conventional rehabilitation only

Procedure: Conventional rehabilitation

Interventions

AcupuncturePROCEDURE

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

Acupuncture
Conventional rehabilitationPROCEDURE

In-patient physiotherapy, occupational therapy and speech therapy.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Cardiac Pacemaker;
  • Patient who is apprehensive to acupuncture;
  • Clotting abnormality;
  • Poor local skin conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, 852, China

Location

MeSH Terms

Conditions

StrokeCerebral Hemorrhage

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • George KC Wong

    Division of Neurosurgery, CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Clinical)

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

CN(1)