Dose Escalation Upper Limb Rehabilitation in Stroke
Study Details
Study Description
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 complete more than 20% 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, 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: participants with acute stroke (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) 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)[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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- Fugl-Meyer Assessment of Motor Recovery after Stroke [day 6]
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.
- Fugl-Meyer Assessment of Motor Recovery after Stroke [day 9]
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.
- Fugl-Meyer Assessment of Motor Recovery after Stroke [day 12]
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.
- Fugl-Meyer Assessment of Motor Recovery after Stroke [day 15]
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 Outcome Measures
- 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.
- Motricity index [day 4]
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.
- Motricity index [day 5]
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.
- Motricity index [day 6]
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.
- Motricity index [day 7]
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.
- Motricity index [day 8]
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.
- Motricity index [day 9]
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.
- Motricity index [day 10]
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.
- Motricity index [day 11]
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.
- Motricity index [day 12]
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.
- Motricity index [day 13]
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.
- Motricity index [day 14]
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.
- Motricity index [day 15]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 4]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 5]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 6]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 7]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 8]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 9]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 10]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 11]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 12]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 13]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 14]
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).
- Visual Analog Scale of Fatigue (VAS-f) [day 15]
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)
- Borg RPE Scale [day 4]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 5]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 6]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 7]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 8]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 9]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 10]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 11]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 12]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 13]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 14]
Measurement of physical activity intensity (6 to 20 scale)
- Borg RPE Scale [day 15]
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")
- Numeric rating scale pain [day 4]
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")
- Numeric rating scale pain [day 5]
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")
- Numeric rating scale pain [day 6]
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")
- Numeric rating scale pain [day 7]
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")
- Numeric rating scale pain [day 8]
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")
- Numeric rating scale pain [day 9]
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")
- Numeric rating scale pain [day 10]
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")
- Numeric rating scale pain [day 11]
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")
- Numeric rating scale pain [day 12]
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")
- Numeric rating scale pain [day 13]
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")
- Numeric rating scale pain [day 14]
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")
- Numeric rating scale pain [day 15]
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")
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ziekenhuis Oost-Limburg | Genk | Belgium | 3600 |
Sponsors and Collaborators
- Hasselt University
- Ziekenhuis Oost-Limburg
Investigators
- Principal Investigator: Peter Feys, prof. dr., Hasselt University
- Study Chair: Lisa Tabone, dr., Hasselt University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DOMINO-001