Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

Stroke Clinical Trial

Official title:

Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037894
• Other study ID #: GW003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 22, 2009
• Last updated: January 10, 2013
• Start date: January 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Conventional rehabilitation
In-patient physiotherapy, occupational therapy and speech therapy.

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale Extended		Six week	No
Secondary	Functional Independence Measure (FIM) score		Six week	No
Secondary	Modified Aschoff Score		Six week	No
Secondary	Neurocognitive State Examination(NCSE)score		Six week	No
Secondary	Motor scores of upper limb and lower limb with Fugl-Meyer Scale		six week	Yes
Secondary	Modified Functional Ambulation Category (MFAC)		Six week	No
Secondary	Modified Rivermead Mobility Index (MRMI)		Six week	No
Secondary	Barthel Index		Six week	Yes
Secondary	Modified Rankin Scale		Six week	No