An interventional study of upper limb rehabilitation in Stroke, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Hasselt University · Not applicable, Interventional, and Treatment
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Hasselt University is the lead sponsor of 203 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(a) a first-ever unilateral, diagnosed stroke by a neurologist as defined by the World Health Organisation, (b) been admitted to the acute hospital for rehabilitation, (c) Upper limb hemiparesis or hemiplegia with a trace of muscle contraction:≥grade 1 at shoulder (abductors or elevators) or wrist/finger extensors measured by the MRC Scale and a score of \<61 on the Motricity Index and severely motor affected by score of 2 or 3 on item number 5 on the NIH Stroke Scale (NIHSS)\[24\], (d) the age of \> 18 years and (e) the ability to provide informed consent.
Other: upper limb rehabilitation
the intervention consisting of two components: a) Upper limb training protocol; b) Technology-assist training.
Fugl-Meyer Assessment of Motor Recovery after Stroke
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.
Time frame: baseline
Fugl-Meyer Assessment of Motor Recovery after Stroke
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.
Time frame: day 6
Fugl-Meyer Assessment of Motor Recovery after Stroke
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.
Time frame: day 9
Fugl-Meyer Assessment of Motor Recovery after Stroke
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.
Time frame: day 12
Fugl-Meyer Assessment of Motor Recovery after Stroke
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.
Time frame: day 15
Motricity index
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.
Time frame: day 3
Motricity index
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.
Time frame: day 4
Motricity index
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.
Time frame: day 5
Motricity index
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.
Time frame: day 6
Motricity index
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.
Time frame: day 7
Motricity index
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.
Time frame: day 8
Motricity index
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.
Time frame: day 9
Motricity index
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.
Time frame: day 10
Motricity index
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.
Time frame: day 11
Motricity index
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.
Time frame: day 12
Motricity index
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.
Time frame: day 13
Motricity index
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.
Time frame: day 14
Motricity index
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.
Time frame: day 15
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 3
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 4
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 5
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 6
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 7
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 8
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 9
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 10
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 11
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 12
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 13
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 14
Visual Analog Scale of Fatigue (VAS-f)
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).
Time frame: day 15
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 3
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 4
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 5
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 6
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 7
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 8
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 9
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 10
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 11
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 12
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 13
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 14
Borg RPE Scale
Measurement of physical activity intensity (6 to 20 scale)
Time frame: day 15
Numeric rating scale pain
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")
Time frame: day 3
Numeric rating scale pain
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")
Time frame: day 4
Numeric rating scale pain
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")
Time frame: day 5
Numeric rating scale pain
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")
Time frame: day 6
Numeric rating scale pain
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")
Time frame: day 7
Numeric rating scale pain
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")
Time frame: day 8
Numeric rating scale pain
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")
Time frame: day 9
Numeric rating scale pain
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")
Time frame: day 10
Numeric rating scale pain
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")
Time frame: day 11
Numeric rating scale pain
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")
Time frame: day 12
Numeric rating scale pain
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")
Time frame: day 13
Numeric rating scale pain
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")
Time frame: day 14
Numeric rating scale pain
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")
Time frame: day 15
Ran from Aug 2021 to primary completion in May 2024, 33 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 33 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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