Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System

NCT01116466 | Completed Results

• 1 other identifier: PB-SA844-100
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator.

Conditions

Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Distance Walked in 6 Minutes

  The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.

  Baseline, 6 and 12 weeks post-implantation

Secondary Outcomes (5)

• Walking Speed During 10 Meter Gait Test

  Baseline, 6 and 12 weeks post-implantation

• Canadian Occupational Performance Measure (COPM) Score

  Baseline,12 weeks post-implantation

• Four Square Step Test (FSST)

  Baseline, week 12 post-implantation

• Nerve Conduction Velocity of the Peroneal Nerve

  Baseline, week 12 post-implantation

• Change in MRI of Affected Leg and Implant Post-implantation

  Week 2 post-implantation

Study Arms (1)

ActiGait

EXPERIMENTAL

Receiving ActiGait - implantable drop foot stimulator

Device: ActiGait

Interventions

ActiGait DEVICE

ActiGait - implantable drop foot stimulator

ActiGait

Eligibility Criteria

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

You may qualify if:

• have a single sided hemiparesis persisting for more than 6 months due to a cerebro-vascular accident (CVA).
• be fully grown-up.
• have the ability to walk 20 meters in less than 2 minutes with or without walking aid but without the help of another person.
• have a reduced speed of walking.
• have the ability to stand upright with both heels touching the floor while hip and knee are in neutral position.
• have a passive range of movement of the affected ankle joint of at least 30 degrees.
• have a positive response to surface electrical stimulation of the peroneal nerve - i.e. muscle contraction which results in dorsiflexion of the ankle and improved gait.
• male or female older than 18 years of age.
• have signed written Informed consent to participate in the study.
• is willing and able to follow all study procedures including attendance at clinics for scheduled study visits.

You may not qualify if:

• peripheral nerve damage of the affected leg.
• severe or uncontrolled diabetes with peripheral nerve involvement.
• poor skin condition on the affected leg.
• a thickness of subcutaneous fat exceeding 3.5 cm in the region of the implant.
• inability to walk 100 meters without stopping prior to CVA (with or without a walking aid, but without the help of another person).
• poorly controlled epilepsy.
• need of Ankle Foot Orthosis (AOF) to maintain ankle stability.
• concomitant medical and psychological conditions which would limit the success of the ActiGait® system such as: active degenerative diseases of the back and lower limbs, visuo-spatial neglect, or drug abuse, personality disorders or poor cognitive function.
• concomitant medical and psychological conditions which would compromise the safety of the patient in connection with the implantation and use of the ActiGait system, such as: severe cardiac disease, uncontrolled hypertension or history of malignancy within the preceding five years.
• other active implanted devices such as demand pacemakers or implanted defibrillators, as mutual electromagnetic interference may distort the efficacy of both systems and expose the patient to dangerous situations.
• history of falls greater than once a week.
• pregnancy and lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator.
• previous participation in this study
• participation in an investigational drug trial within 4 weeks prior to enrolment.
• requirement of an interpreter

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Affairs Manager
• Organization: Otto Bock Healthcare Products GmbH

Milana.Mileusnic@ottobock.com

004315233786733

Study Officials

• David Liebetanz, MD

  Medical University Georg-August-University Goettingen, Germany

  PRINCIPAL INVESTIGATOR

• Veit Rhode, MD

  Medical University Georg-August-University Goettingen, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 5, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 26, 2021
• Results First Posted: November 17, 2014

Record last verified: 2021-06