Study of Sensory Deficits in the Upper Limb After Stroke

Stroke Clinical Trial

Official title:

Prospective Longitudinal Study: Sensory Deficits in the Upper Limb After Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685788
• Other study ID #: KUL - FaBeR - Stroke - Meyer
• Status: Completed
• Phase: N/A
• First received: September 6, 2012
• Last updated: October 25, 2016
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	activity measure	The investigators will use the ABILHAND Questionnaire, a measure of how well the hemiplegic arm and hand can be used in daily activities.	6 months post stroke	No
Other	Activity measure	The Assisting Hand Assessment (AHA) will be used to investigate the use of the hemiplegic arm in bimanual tasks after stroke.	6 months after stroke	No
Other	Participation measure	The quality of life will be measured using the Stroke Impact Scale.	6 months after stroke	No
Primary	Change in sensory function in upper limb from baseline up to 6 months post stroke		6 months post stroke	No
Secondary	Change in motor function in upper limb from baseline up to 6 months post stroke		6 months post stroke	No