Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity

Completed

Phase N/A Results N/A

Trial Description

Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.

Detailed Description

Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.

Conditions

Interventions

  • BtxA+mCIMT Other
    Other Names: the combination group
    Intervention Desc: The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
    ARM 1: Kind: Experimental
    Label: 1
    Description: BtxA+mCIMT (combination group)
  • BtxA+ conventional rehabilitation Other
    Other Names: the control group
    Intervention Desc: The control group received for 2 hours/day, 3 days/week for 3 months.
    ARM 1: Kind: Experimental
    Label: 2
    Description: BtxA+ conventional rehabilitation (control group)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary outcome assessed spasticity on the Modified Ashworth Scale. MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection. Yes
Secondary Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction. evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection. Yes

Sponsors