Stroke
Conditions
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.
Interventions
the intervention consisting of two components: a) Upper limb training protocol; b) Technology-assist training.
Sponsors
Ziekenhuis Oost-Limburg
Hasselt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of Motor Recovery after Stroke | baseline | a stroke-specific, performance-based impairment index.The scale is comprised of five domains and there are 155 items in total (motor functioning, sensory functioning, balance, joint range motion, joint pain). Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motricity index | day 3 | Measurement of upper limb strength. The weighted score based on the ordinal 6 point scale of Medical Research Council was used to measure maximal isometric muscle strength. |
| Visual Analog Scale of Fatigue (VAS-f) | day 3 | The scale consists of 18 items relating to the subjective experience of fatigue.Each line is 100 mm in length - thus, scores fall between 0 and 100. The instrument also possesses two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). |
| Borg RPE Scale | day 3 | Measurement of physical activity intensity (6 to 20 scale) |
| Numeric rating scale pain | day 3 | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) |
Countries
Belgium
Outcome results
None listed