The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment

NCT ID: NCT01988220

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-12-31

Brief Summary

Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory deficits. Sensory impairments are often overlooked in the therapeutic setting, although they lead to slower motor recovery.

Working hypothesis: The overall goal of this study is to examine the effectiveness of a sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke patients with sensory impairments. We assume that subjects to both groups will make progress, which will be more significant in the experimental group.

Methods: Study population and design: Sixty individuals with chronic sensory impairment following a stroke will be recruited. Patients will be randomly assigned to sensory retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45 minute long intervention sessions, carried out within a 6 weeks period, and a home exercise program. The person conducting the assessments will be blind to the treatment allocation of the subjects. Outcome measures: The efficacy of the intervention will be determined in relation to the International Classification of Functionality (ICF) developed by the World Health Organization and will include assessments at the three domains defined by this model: 1. Body structure and function - determined by measures of the sensory capacity of the lower more affected limb; 2. Activities - determined by measures of balance and gait; 3. Participation - determined by measures of well-being and social reintegration.

Two new outcome measures, for ankle and knee position sense and for texture discrimination of the foot, will be developed within this study. Data reliability measures on healthy population, and test - retest measures in post stroke population with be collected.

Intervention: The experimental group will be treated by a perception learning oriented protocol for sensory reeducation, to improve identification, localization and discrimination of sensory stimuli, including electrical stimulation, texture and hardness discrimination and position sense training. The control group will receive the same stimuli without the attentive learning and discriminating component.

Importance: Scientific proof and focused recommendations for a potent therapeutic method for the post-stroke population, allowing them better participation and quality of life.

Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.

Conditions

Stroke; Sensory Deficits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sensory retraining

sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining

Group Type: EXPERIMENTAL

sensory retraining

Intervention Type: OTHER

repeated exposure to sensory input

Group Type: ACTIVE_COMPARATOR

repeated sensory input

Intervention Type: OTHER

sensory stimulation without attentive learning focus

Interventions

sensory retraining

Intervention Type: OTHER

repeated sensory input

sensory stimulation without attentive learning focus

Intervention Type: OTHER

Other Intervention Names

perceptual learning; sensory reeducation

Eligibility Criteria

Inclusion Criteria

• post stroke
• at least 6 months after stroke
• with sensory deficits in study's screening tests

Exclusion Criteria

• other neurologic condition
• peripheral neuropathy
• pacemaker
• hemispatial neglect

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

Sponsors

Clalit Health Services, Haifa and West Galilee

OTHER

Sponsor Role: collaborator

Yocheved Laufer

OTHER

Sponsor Role: lead

Responsible Party

Yocheved Laufer

Chair, Physical Therapy Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mordechai Alperin, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Hadas Ofek, PhD student

Role: STUDY_DIRECTOR

University of Haifa

Yocheved Laufer, Professor

Role: STUDY_CHAIR

University of Haifa

Uzi Milman, MD

Role: STUDY_CHAIR

Clalit Health Services

Locations

Physical therapy clinics Clalit Health services

Haifa District, , Israel

Countries

Israel

References

Ofek H, Alperin M, Knoll T, Livne D, Laufer Y. Explicit versus implicit lower extremity sensory retraining for post-stroke chronic sensory deficits: a randomized controlled trial. Disabil Rehabil. 2023 Jun;45(12):1962-1968. doi: 10.1080/09638288.2022.2080288. Epub 2022 Jun 1.

Reference Type: DERIVED

PMID: 35649684 (View on PubMed)

Other Identifiers

UHai012013

Identifier Type: -

Identifier Source: org_study_id