Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Therapeutic Effect of Amphetamine in Association to Physiotherapy on Motor Recovery After Stroke: a Randomised, Double-Blinded, Placebo-Controlled Trial|
- Chedoke-McMaster Stroke Assessment (motor impairment measure) [ Time Frame: Over the whole duration of the study (2001 to 2006, ten times for each patient) ] [ Designated as safety issue: No ]
|Study Start Date:||January 2001|
|Study Completion Date:||September 2006|
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.
|Placebo Comparator: 2||
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.