Toe Walker Gait Trial (TW)

Dynasplint Systems.

Status: Terminated

Conditions: Gait

Treatments: Device: Ankle Flexion Dynasplint; Other: standard of care treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01208142

2010.001

Details and patient eligibility

About

The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers.

For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.

Enrollment: 10 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Toe Walking secondary to CP
• Idiopathic TW
• Inability to ambulate with initial heel-contact
• Inability to bear weight and stand flat-footed for over one minute
• Inability to stand or hop on one foot (symptomatic) for more than one minute

Exclusion criteria

• Acid Maltase Deficiency Myopathy
• Acute Paralytic Poliomyelitis
• Spinal Muscular Atrophy-all types
• Stroke, ischemic or hemorrhagic, all types
• Multiple Sclerosis
• Traumatic Brain Injury (including Shaken Baby Syndrome)
• Unilateral ROM deficits in Knee or Hip
• Previous Achilles Tendon lengthening surgery
• Hemiplegic Cerebral Palsy
• Muscular Dystrophy-all types

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO).

Treatment:

Other: standard of care treatment

Dynasplint

Experimental group

Description:

25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint

Treatment:

Device: Ankle Flexion Dynasplint