Dose Escalation Upper Limb Rehabilitation in Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973553
• Other study ID #: DOMINO-001
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: May 27, 2024

Study information

• Verified date: May 2024
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 27, 2024
• Est. primary completion date: May 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	day 6
Primary	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.	day 9
Primary	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.	day 12
Primary	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.	day 15
Secondary	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.	day 3
Secondary	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.	day 4
Secondary	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.	day 5
Secondary	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.	day 6
Secondary	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.	day 7
Secondary	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.	day 8
Secondary	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.	day 9
Secondary	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.	day 10
Secondary	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.	day 11
Secondary	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.	day 12
Secondary	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.	day 13
Secondary	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.	day 14
Secondary	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.	day 15
Secondary	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).	day 3
Secondary	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).	day 4
Secondary	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).	day 5
Secondary	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).	day 6
Secondary	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).	day 7
Secondary	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).	day 8
Secondary	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).	day 9
Secondary	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).	day 10
Secondary	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).	day 11
Secondary	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).	day 12
Secondary	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).	day 13
Secondary	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).	day 14
Secondary	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).	day 15
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 3
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 4
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 5
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 6
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 7
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 8
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 9
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 10
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 11
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 12
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 13
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 14
Secondary	Borg RPE Scale	Measurement of physical activity intensity (6 to 20 scale)	day 15
Secondary	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")	day 3
Secondary	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")	day 4
Secondary	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")	day 5
Secondary	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")	day 6
Secondary	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")	day 7
Secondary	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")	day 8
Secondary	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")	day 9
Secondary	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")	day 10
Secondary	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")	day 11
Secondary	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")	day 12
Secondary	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")	day 13
Secondary	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")	day 14
Secondary	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")	day 15