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Therapeutic Exercise for Patients With Stroke

Study acronym: EINTER
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 2 → 3 primary endpoints
See other at-risk trials from Instituto de Investigación Sanitaria Aragón

Record History

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  1. Notable Primary endpoint(s) modified Show 11 more changesShow less
    • Phase changed: not specified → not applicable
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Final enrollment: 35 participants (planned 30)
    • Primary completion date changed from estimate of Dec 31, 2026 to Oct 1, 2026
    • Study completion moved earlier from Feb 15, 2027 to Oct 15, 2026
    • Interventions modified
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoint revised
    • Study description shortened, about 710 words
    • Study site revised
    • Publications: details revised at 5 of 5 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this prospective, single-centre, non-randomized, single-arm interventional study is to evaluate changes in muscle strength, lower-limb functional capacity, aerobic endurance, and patient satisfaction following participation in the EINTER group-based therapeutic exercise programme in adults with post-stroke impairments admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza, Spain. Participants will be assigned to receive the EINTER programme during their hospital stay. The programme combines supervised aerobic and progressive strength training and is delivered in small groups of up to four patients per physiotherapist for a maximum of four weeks. Functional assessments will be performed before starting the programme and after completion of the intervention or at hospital discharge. Muscle strength will be assessed using the Medical Research Council scale, lower-limb functional capacity using the 30-Second Sit-to-Stand Test, and aerobic endurance and walking capacity using the 2-Minute Walk Test. Participant satisfaction will also be assessed at the end of the programme. There will be no control group or random allocation. Changes in outcomes will therefore be evaluated using within-participant pre-post comparisons.
Trial Details
NCT Number NCT07736794
Lead Sponsor Instituto de Investigación Sanitaria Aragón
Conditions
(from sponsor)
Stroke
Related terms Motor Activity, Stroke
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov