N/A
N=96
Altering Activation Patterns Post-stroke
Stroke · Muscle Spasticity · Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT02418949 ↗Enrolled (actual)
96
Serious AEs
5.2%
Results posted
Jul 2021
Primary outcome: Primary: Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT) — -3.66; -0.51; -4.00; -3.89 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cyproheptadine (Drug); Placebo for Cyproheptadine (Drug); Active Movement Practice (AMP) (Other); Passive Cyclical Stretching (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT) |
-3.66; -0.51; -4.00; -3.89 | — |
| SECONDARY Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC) |
-1.66; -0.96; -1.06; -2.65 | — |
Summary
This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.
Eligibility Criteria
Inclusion Criteria
- Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3)
- Single stroke occurring at least 6 months prior to enrollment
- Spasticity
- Capacity to provide informed consent
Exclusion Criteria
- Excessive pain in paretic upper limb
- Hemispatial neglect (as assessed by the Behavioral Inattention Test)
- Apraxia (as assessed by the FABERS battery)
- Botulinum toxin injection in the upper extremity within the past 6 months
- Introduction of new anti-spasticity medication within the past 6 months
- Orthopaedic impairments
- History of seizure disorder
- Other major health impairment
Data sourced from ClinicalTrials.gov (NCT02418949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.