Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke

Terminated

Phase 4 Results N/A

Trial Description

The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial.
Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks.
The outcome measure focuses on motor recovery and will be assessed:
- one and two weeks before study intervention (baseline phase)
- five times during the study intervention
- one week after study intervention (follow-up)
- once after six and twelve months after start of the study intervention (follow-up).

Trial Stopped: Intended length of study ended

Conditions

Interventions

  • Dextro-Amphetamin Drug
    Intervention Desc: After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
    ARM 1: Kind: Experimental
    Label: 1
  • Glucose Other
    Intervention Desc: After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour. The treatment of the control group will be the same as for the experimental group except the content of the drug capsule.
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Chedoke-McMaster Stroke Assessment (motor impairment measure) Over the whole duration of the study (2001 to 2006, ten times for each patient) No

Sponsors