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OpenTrials
Completed

NCT Number: NCT01037894

Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Prince of Wales Hospital

Hong Kong, 852, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient inclusion Criteria:

  • 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;

Patient exclusion Criteria:

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

Treatment and study plan

Acupuncture

Procedure

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

Procedure

In-patient physiotherapy, occupational therapy and speech therapy.

Primary outcomes

  1. Glasgow Outcome Scale Extended

    Time frame: Six week

Secondary outcomes

  1. Functional Independence Measure (FIM) score

    Time frame: Six week

  2. Modified Aschoff Score

    Time frame: Six week

  3. Neurocognitive State Examination(NCSE)score

    Time frame: Six week

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

    Time frame: six week

  5. Modified Functional Ambulation Category (MFAC)

    Time frame: Six week

  6. Modified Rivermead Mobility Index (MRMI)

    Time frame: Six week

  7. Barthel Index

    Time frame: Six week

  8. Modified Rankin Scale

    Time frame: Six week

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2009
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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