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Dose Escalation Upper Limb Rehabilitation in Stroke

NCT04973553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

upper limb rehabilitation

the intervention consisting of two components: a) Upper limb training protocol; b) Technology-assist training.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • Hasselt University

    lead OTHER

Principal Investigators

  • Peter Feys, prof. dr. · Hasselt University

  • Lisa Tabone, dr. · Hasselt University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2024-05-27
Completion
2024-05-27

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973553 on ClinicalTrials.gov