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Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia

2014-07-23 21:56:49 | BioPortfolio

Summary

OBJECTIVES:

I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.

Description

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by age and the ability to ambulate 50 feet unaided. Each stratum is block randomized.

Patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone.

The surgical procedure is a selective dorsal rhizotomy. Physical therapy (PT) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. The PT schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). Parents supervise exercise on non-PT days.

Patients are followed at 6, 12, and 24 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Conditions

Spastic Diplegia

Intervention

Surgery, Physical therapy

Status

Active, not recruiting

Source

Office of Rare Diseases (ORD)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:56:49-0400

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Medical and Biotech [MESH] Definitions

A heterogeneous group of nonprogressive motor disorders caused by chronic brain injuries that originate in the prenatal period, perinatal period, or first few years of life. The four major subtypes are spastic, athetoid, ataxic, and mixed cerebral palsy, with spastic forms being the most common. The motor disorder may range from difficulties with fine motor control to severe spasticity (see MUSCLE SPASTICITY) in all limbs. Spastic diplegia (Little disease) is the most common subtype, and is characterized by spasticity that is more prominent in the legs than in the arms. Pathologically, this condition may be associated with LEUKOMALACIA, PERIVENTRICULAR. (From Dev Med Child Neurol 1998 Aug;40(8):520-7)

Therapeutic modalities frequently used in PHYSICAL THERAPY (SPECIALTY) by physical therapists or physiotherapists to promote, maintain, or restore the physical and physiological well-being of an individual.

Persons trained in PHYSICAL THERAPY SPECIALTY to make use of PHYSICAL THERAPY MODALITIES to prevent, correct, and alleviate movement dysfunction.

The auxiliary health profession by which PHYSICAL THERAPISTS make use of PHYSICAL THERAPY MODALITIES to prevent, correct, and alleviate movement dysfunction of anatomic or physiological origin.

The auxiliary health profession which makes use of PHYSICAL THERAPY MODALITIES to prevent, correct, and alleviate movement dysfunction of anatomic or physiologic origin.

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