Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

NCT03556709 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HP-00080575
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to test the utility of an ankle robot, when used during treadmill walking, in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

Conditions

Foot Drop; Peripheral Nervous System Diseases; Gait Disorders, Neurologic; Mobility Limitation

Outcome Measures

Primary Outcomes (6)

• Gait velocity during self-selected overground walking

  cm/sec

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Peak dorsiflexion angle during swing phase of gait

  degrees; extent of ankle dorsiflexion to enable foot clearance

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Ankle dorsiflexion-plantarflexion range of motion

  degrees

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Postural sway areas during quiet standing

  cm\^2; extent of postural deviations to assess static postural control

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Ratio of asymmetric loading in quiet standing

  ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Push-off forces during gait initiation

  Newtons; magnitude of forward ground reaction forces.

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

Study Arms (1)

Treadmill Ankle Robot Training

EXPERIMENTAL

Device: Treadmill Ankle Robot Training

Interventions

Treadmill Ankle Robot Training DEVICE

This intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.

Treadmill Ankle Robot Training

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged 18 to 88 years
• Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
• Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device\[s\] is permitted)

You may not qualify if:

• Cardiac history of (a) unstable angina; (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); and/or (c) hemodynamically significant valvular dysfunction
• Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments)
• Medical history of (a) recent hospitalization (less than 3 months) for severe medical disease; (b) symptomatic peripheral arterial occlusive disease; (c) orthopedic or chronic pain conditions that significantly alter gait function; (d) pulmonary or renal failure; and/or (e) active cancer
• Current participation in orthopedic or rehabilitation medical programs
• Active deep venous thrombosis
• Distal paretic leg skin lesions, infections, or soft tissue inflammation

Sponsors & Collaborators

• Baltimore VA Medical Center: lead

MeSH Terms

Conditions

Peroneal Neuropathies; Peripheral Nervous System Diseases; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlene E. Hafer-Macko, M.D.

  Baltimore VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate C. Flores

CONTACT

(410) 637-3242; kate.flores@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: August 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share