Dose Escalation Upper Limb Rehabilitation in Stroke

NCT ID: NCT04973553

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2024-05-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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) 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.

Group Type: EXPERIMENTAL

upper limb rehabilitation

Intervention Type: OTHER

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

Interventions

upper limb rehabilitation

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Peter Feys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Feys, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Lisa Tabone, dr.

Role: STUDY_CHAIR

Hasselt University

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 40579997 (View on PubMed)

Other Identifiers

DOMINO-001

Identifier Type: -

Identifier Source: org_study_id