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Completed

NCT Number: NCT04973553

Dose Escalation Upper Limb Rehabilitation in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Upper Limb Rehabilitation

Other

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

Primary outcomes

  1. Fugl-Meyer Assessment of Motor Recovery after Stroke

    Time frame: 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.

  2. Fugl-Meyer Assessment of Motor Recovery after Stroke

    Time frame: 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.

  3. Fugl-Meyer Assessment of Motor Recovery after Stroke

    Time frame: 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.

  4. Fugl-Meyer Assessment of Motor Recovery after Stroke

    Time frame: 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.

  5. Fugl-Meyer Assessment of Motor Recovery after Stroke

    Time frame: 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 outcomes

  1. Motricity index

    Time frame: 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.

  2. Motricity index

    Time frame: 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.

  3. Motricity index

    Time frame: 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.

  4. Motricity index

    Time frame: 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.

  5. Motricity index

    Time frame: 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.

  6. Motricity index

    Time frame: 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.

  7. Motricity index

    Time frame: 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.

  8. Motricity index

    Time frame: 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.

  9. Motricity index

    Time frame: 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.

  10. Motricity index

    Time frame: 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.

  11. Motricity index

    Time frame: 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.

  12. Motricity index

    Time frame: 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.

  13. Motricity index

    Time frame: 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.

  14. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  15. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  16. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  17. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  18. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  19. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  20. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  21. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  22. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  23. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  24. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  25. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  26. Visual Analog Scale of Fatigue (VAS-f)

    Time frame: 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).

  27. Borg RPE Scale

    Time frame: day 3

    Measurement of physical activity intensity (6 to 20 scale)

  28. Borg RPE Scale

    Time frame: day 4

    Measurement of physical activity intensity (6 to 20 scale)

  29. Borg RPE Scale

    Time frame: day 5

    Measurement of physical activity intensity (6 to 20 scale)

  30. Borg RPE Scale

    Time frame: day 6

    Measurement of physical activity intensity (6 to 20 scale)

  31. Borg RPE Scale

    Time frame: day 7

    Measurement of physical activity intensity (6 to 20 scale)

  32. Borg RPE Scale

    Time frame: day 8

    Measurement of physical activity intensity (6 to 20 scale)

  33. Borg RPE Scale

    Time frame: day 9

    Measurement of physical activity intensity (6 to 20 scale)

  34. Borg RPE Scale

    Time frame: day 10

    Measurement of physical activity intensity (6 to 20 scale)

  35. Borg RPE Scale

    Time frame: day 11

    Measurement of physical activity intensity (6 to 20 scale)

  36. Borg RPE Scale

    Time frame: day 12

    Measurement of physical activity intensity (6 to 20 scale)

  37. Borg RPE Scale

    Time frame: day 13

    Measurement of physical activity intensity (6 to 20 scale)

  38. Borg RPE Scale

    Time frame: day 14

    Measurement of physical activity intensity (6 to 20 scale)

  39. Borg RPE Scale

    Time frame: day 15

    Measurement of physical activity intensity (6 to 20 scale)

  40. Numeric rating scale pain

    Time frame: 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")

  41. Numeric rating scale pain

    Time frame: 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")

  42. Numeric rating scale pain

    Time frame: 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")

  43. Numeric rating scale pain

    Time frame: 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")

  44. Numeric rating scale pain

    Time frame: 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")

  45. Numeric rating scale pain

    Time frame: 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")

  46. Numeric rating scale pain

    Time frame: 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")

  47. Numeric rating scale pain

    Time frame: 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")

  48. Numeric rating scale pain

    Time frame: 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")

  49. Numeric rating scale pain

    Time frame: 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")

  50. Numeric rating scale pain

    Time frame: 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")

  51. Numeric rating scale pain

    Time frame: 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")

  52. Numeric rating scale pain

    Time frame: 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")

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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