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Rehabilitation

Phase 1

Stroke | Unknown | Neurology |United Therapeutics Corporation|Last Updated: Mar 19, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02429180Rehabilitation Training After StrokePHASE1 COMPLETED 48Jul 31, 2015Jan 27, 2016Mar 19, 20191 United Kingdom
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Study Endpoints
Primary Endpoints
Change in Rivermead Mobility index
Baseline, 6 months, 9 months

15-item, dichotomously scored measure of mobility disability. Fourteen items are self-report and one (standing for 10s without aids) is scored by observation

Change in Timed Up and Go Test
Baseline, 6 months, 9 months

Objective measure of mobility, balance and locomotor performance, in which the individual is observed and timed rising from a chair, walking 3m, turning and returning to the chair

Change in Modified Patient Specific Functional Scale
Baseline, 6 months, 9 months

Identification by individual of up to five functional tasks that are important and difficult to perform, and rating of ability to perform each task on a 0-10 scale

Change in Physical Activity Diary
Baseline, 6 months, 9 months

Participants record the type of activity and its duration each day of the week (1-2 minutes per day to complete).

Change in Physical activity - 7-day accelerometry
Baseline, 6 months, 9 months

Worn by individual to assess physical activity behaviour over seven days. Should take 5 minutes to fit watch and 10 minutes to post back

Secondary Endpoints
Fatigue Assessment Scale
Baseline, 6 months, 9 months
Stroke Self-efficacy Questionnaire
Baseline, 9 months
Exercise beliefs questionnaire
Baseline, 9 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rehabilitation trainingEXPERIMENTALReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase. * Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals * Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression. * Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme * Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression.
ControlNO_INTERVENTIONControl: treatment as usual plus receipt of a UK Stroke Association booklet on exercise after stroke.
Interventions
NameTypeDescription
RehabilitationOTHERReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase. * Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals * Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression. * Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme * Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Primary clinical diagnosis of stroke (assessed by referring clinician/GP records) * \>1 month (but no upper limit) since discharge from NHS physical rehabilitation services at randomisation * Able to walk independently indoors with or without mobility aids, but has self-report...

Countries:United Kingdom
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