Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

Completed

Phase 1/2 Results N/A

Trial Description

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

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

Interventions

  • Acupuncture Device
    Other Names: disposable stainless steel needles (0.30 mm×40 mm for body acupoints, 0.30 mm×30 mm for scalp acupoints, Dong Bang Acupuncture Inc.Korea,
    Intervention Desc: Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.
    ARM 1: Kind: Experimental
    Label: Acupuncture
    Description: Acupuncture and conventional rehabilitation
  • Conventional rehabilitation Behavioral
    Other Names: CR
    Intervention Desc: In-patient physiotherapy, occupational therapy and speech therapy.
    ARM 1: Kind: Experimental
    Label: Control
    Description: Conventional rehabilitation only

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure 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

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