Clinical trial NCT04973553: Dose Escalation Upper Limb Rehabilitation in Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2021-07-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. a first-ever unilateral, diagnosed stroke by a neurologist as defined by the World Health Organisation,
2. been admitted to the acute hospital for rehabilitation,
3. 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),
4. the age of \> 18 years and (e) the ability to provide informed consent.

Exclusion Criteria:

1. other neurological impairments that could interfere with the protocol such as multiple sclerosis and Parkinson's
2. serious communication, cognitive and language deficits which might hamper the assessment (score of \>1 on the command item of the NIHSS).

Primary outcomes:
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: baseline
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: day 6
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: day 9
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: day 12
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: day 15
Secondary outcomes:
measure: Motricity index
timeFrame: day 3
measure: Motricity index
timeFrame: day 4
measure: Motricity index
timeFrame: day 5
measure: Motricity index
timeFrame: day 6
measure: Motricity index
timeFrame: day 7
measure: Motricity index
timeFrame: day 8
measure: Motricity index
timeFrame: day 9
measure: Motricity index
timeFrame: day 10
measure: Motricity index
timeFrame: day 11
measure: Motricity index
timeFrame: day 12
measure: Motricity index
timeFrame: day 13
measure: Motricity index
timeFrame: day 14
measure: Motricity index
timeFrame: day 15
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 3
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 4
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 5
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 6
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 7
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 8
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 9
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 10
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 11
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 12
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 13
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 14
measure: Visual Analog Scale of Fatigue (VAS-f)
timeFrame: day 15
measure: Borg RPE Scale
timeFrame: day 3
measure: Borg RPE Scale
timeFrame: day 4
measure: Borg RPE Scale
timeFrame: day 5
measure: Borg RPE Scale
timeFrame: day 6
measure: Borg RPE Scale
timeFrame: day 7
measure: Borg RPE Scale
timeFrame: day 8
measure: Borg RPE Scale
timeFrame: day 9
measure: Borg RPE Scale
timeFrame: day 10
measure: Borg RPE Scale
timeFrame: day 11
measure: Borg RPE Scale
timeFrame: day 12
measure: Borg RPE Scale
timeFrame: day 13
measure: Borg RPE Scale
timeFrame: day 14
measure: Borg RPE Scale
timeFrame: day 15
measure: Numeric rating scale pain
timeFrame: day 3
measure: Numeric rating scale pain
timeFrame: day 4
measure: Numeric rating scale pain
timeFrame: day 5
measure: Numeric rating scale pain
timeFrame: day 6
measure: Numeric rating scale pain
timeFrame: day 7
measure: Numeric rating scale pain
timeFrame: day 8
measure: Numeric rating scale pain
timeFrame: day 9
measure: Numeric rating scale pain
timeFrame: day 10
measure: Numeric rating scale pain
timeFrame: day 11
measure: Numeric rating scale pain
timeFrame: day 12
measure: Numeric rating scale pain
timeFrame: day 13
measure: Numeric rating scale pain
timeFrame: day 14
measure: Numeric rating scale pain
timeFrame: day 15
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Lisa Tabone, dr.
role: STUDY_CHAIR
References: