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

NCT01988220 | Completed

• 1 other identifier: UHai012013
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; sensory deficit; sensory retraining; perceptual learning; lower extremity

Outcome Measures

Primary Outcomes (1)

• Change in Timed Up and Go test

  Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.

  pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after

Secondary Outcomes (1)

• Von Frey monofilaments foot identification threshold

  screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after

Study Arms (2)

sensory retraining

EXPERIMENTAL

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

Other: sensory retraining

repeated exposure to sensory input

ACTIVE COMPARATOR

Other: repeated sensory input

Interventions

sensory retraining OTHER

Also known as: perceptual learning, sensory reeducation

sensory retraining

repeated sensory input OTHER

sensory stimulation without attentive learning focus

repeated exposure to sensory input

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yocheved Laufer: lead
• Clalit Health Services, Haifa and West Galilee: collaborator

Study Sites (1)

Physical therapy clinics Clalit Health services

Haifa District, Israel

Location

Related Publications (1)

• 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.

  PMID: 35649684 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

• Mordechai Alperin, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

• Hadas Ofek, PhD student

  University of Haifa

  STUDY DIRECTOR

• Yocheved Laufer, Professor

  University of Haifa

  STUDY CHAIR

• Uzi Milman, MD

  Clalit Health Services

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Physical Therapy Department

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

IL (1)