NCT04973553Completed
Dose Escalation Upper Limb Rehabilitation in Stroke
Finding the Optimal Session Length of Upper Limb Rehabilitation of People With Moderate to Severe Upper Limb Sensorimotor Impairments After Acute Stroke: A Dose Escalation Study
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
A phase 1, single-ascending dose clinical trial will be conducted. This study will be designed to test increasing doses of multimodal exercise in successive cohorts of six participants (cumulative 3 + 3 design)\[22\] (Figure 1). Maximum dose is reached when two or more participants experience DLT. DLT, dose-limiting tolerance. The 'dose' will be defined as the ability to reach a fixed maximal level of exercise (type, duration (including session length) in the first two weeks post-stroke without experiencing dose-limiting tolerance (DLT). DLT thresholds will be based on failure to completeshould be less than 80% of prescribed 3-day rehabilitation dose due to pain, rate of perceived exertion, fatigue, or effort required. Rehabilitation and measurement sessions will be held at either at the Stroke or Geriatric Units at Campus Sint-Jan, Genk or at the rehabilitation unit at Sint-Barbara, Lanaken and Cliniques Saint-Luc with medical services on site. All participants will be monitored for fatigue and pain pre, during and at post-intervention daily. The researchers (PI of project \[Dr Peter Hallet, ZOL\] Postdoctoral Researcher \[Dr Lisa Tedesco Triccas, UHasselt\] and PhD/Masters Students \[UHasselt) will conduct the clinical tests and will conduct the rehabilitation program.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 13 Jul 2021
- Start date
- 20 Aug 2021
- Primary completion date
- 27 May 2024
- Lead sponsor
- Hasselt University
- Diseases
- Stroke
- NCT number
- NCT04973553
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 20 Aug 2021 to the primary completion date, 27 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- other neurological impairments that could interfere with the protocol such as multiple sclerosis and Parkinson's
- serious communication, cognitive and language deficits which might hamper the assessment (score of \>1 on the command item of the NIHSS).
Who the study is looking for
- a first-ever unilateral, diagnosed stroke by a neurologist as defined by the World Health Organisation,
- been admitted to the acute hospital for rehabilitation,
- UL hemiparesis or hemiplegia with a ≥ trace of muscle contraction (≥grade 1 at wrist extensors measured by the MRC Scale and severely motor affected by score of 2 or 3 on item number 5 on the NIH Stroke Scale (NIHSS),
- the age of \> 18 years and (e) the ability to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.