Evaluation of the Genu Neurexa Orthosis in Post Stroke Patients

NCT01395576 | Terminated Phase 2

• 1 other identifier: GENU-HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Post stroke patients often suffer from decrease in strength, loss of balance and gait asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury. The presence of spastic or retracted muscles, e.g. the ankle plantar flexors or the quadriceps in combination with hamstrings weakness, causes knee hyperextension, which increases the stance phase duration and makes it difficult to achieve symmetrical gait. Additionally, this gait disorder can be painful as a result of stress to the ligaments and tendons at the posterior aspect of the knee. The Genu Neurexa orthosis is designed to stabilize the knee, enable balance control and prevent hyperextension. In order to assess the effect of the orthosis on the gait and balance characteristics of stroke patients the investigators will conduct subjective patient's satisfactory questionnaire, complete physical and functional evaluation and gait analysis, as well as dynamic electromyography (EMG) muscle activation patterns. These examinations will be performed 3 times: at the beginning of the trial, after one month and after two months. The trial design is explained in the following paragraph. The investigators hypothesize that the gait pattern will be improved while using the knee orthosis,as will be expressed by smaller base width and faster walking velocity etc.

Conditions

Stroke

Keywords

Genu recurvatum; Knee hyper extension; Orthosis; Gait analysis; Post stroke

Outcome Measures

Primary Outcomes (1)

• Spatiotemporal parameters

  stride time, step time, stance duration, swing duration, double support duration, stride length, step length, base width, toe out angle, cadence and velocity

  Up to 3 months

Secondary Outcomes (3)

• Dynamic EMG recordings

  Up to 3 months

• Sagittal angle of the paretic knee

  Up to 3 months

• Functional evaluation

  Up to 3 months

Interventions

Genu Neurexa orthosis DEVICE

Knee orthosis for the prevention of knee hyper extension

Eligibility Criteria

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

You may qualify if:

• Patients suffering a first stro(at least 3 months post stroke)
• Cognitive and cooperative ability to follo instructions.
• Patients suffering from paresis of leg muscles resulting in knee hyperextension.
• Ability to walk with or without a walking aid (cane, walker) independently

You may not qualify if:

• Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
• Skin disease or wounds at the paretic knee
• Ankle or foot contructure or limited range of motion
• Orthopaedic injury to the paretic or non-paretic limbs

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Otto Bock Healthcare Products GmbH: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2011
• First Posted: July 15, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2012-10

Locations

IL (1)