Study of Sensory Deficits in the Upper Limb After Stroke

NCT01685788 | Completed DMC

• 1 other identifier: KUL - FaBeR - Stroke - Meyer
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the project is to gain insight in sensory deficits and recovery patterns in the upper limb post stroke and its association with brain lesion localisation. Furthermore, the investigators will identify associations of deficits in sensory modalities with upper limb impairments, activities and participation at different time points after stroke. Identification of the sensory deficits, along with further insights in their relation with objective neurophysiological and neuroanatomical measures will contribute to the amelioration of goal-setting for the rehabilitation of upper extremity function after stroke. These functions are indispensable during several daily activities as well in different sports and leisure activities. This project is an important step towards a better delineating of treatment interventions for the upper limb and to a better guiding of individual needs for post-stroke treatment in the future.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in sensory function in upper limb from baseline up to 6 months post stroke

  6 months post stroke

Secondary Outcomes (1)

• Change in motor function in upper limb from baseline up to 6 months post stroke

  6 months post stroke

Other Outcomes (3)

• activity measure

  6 months post stroke

• Activity measure

  6 months after stroke

• Participation measure

  6 months after stroke

Study Arms (1)

study participants

Other: No intervention

Interventions

No intervention OTHER

study participants

Eligibility Criteria

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

Study Population

stroke patients

You may qualify if:

• first-ever stroke as defined by WHO
• ≤ 5 days post stroke
• motor impairment and/or a sensory impairment
• ≥ 18 years old
• sufficient cooperation to execute evaluations

You may not qualify if:

• other neurological impairments such as previous stroke, head injury or multiple sclerosis (these might affect sensory ability independently of the stroke)
• stroke-like symptoms caused by subdural hematoma, tumour, encephalitis or trauma
• no informed consent
• pre-stroke Barthel Index \< 95 out of 100 points (to be able to distinguish between pre-existing disabilities and disabilities resulting from the stroke)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Geert Verheyden, Professor

  Catholic University Leuven

  PRINCIPAL INVESTIGATOR

• Sarah Meyer, PhD student

  Catholic University Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 14, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

BE (1)