Dose Escalation Upper Limb Rehabilitation in Stroke

NCT04973553 | Completed

• 1 other identifier: DOMINO-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (52)

• Motricity index

  day 3

• Motricity index

  day 4

• Motricity index

  day 5

• Motricity index

  day 6

• Motricity index

  day 7

Study Arms (1)

participants with acute stroke

EXPERIMENTAL

(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

Interventions

upper limb rehabilitation OTHER

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

participants with acute stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

• Triccas LT, Hallet P, Cardeynaels S, Ward N, Bertels N, Thijs L, Lejeune T, Lamers I, Spooren A, Feys P. Higher Doses of Intensive Upper Limb Rehabilitation for Moderate to Severe Impairment in Acute, Subacute Stroke: Phase I Dose Escalation Study. Neurorehabil Neural Repair. 2025 Sep;39(9):752-764. doi: 10.1177/15459683251338797. Epub 2025 Jun 28.

  PMID: 40579997 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Lisa Tabone, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: August 20, 2021
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

BE (1)