Multicenter Schroth Exercise Trial for Scoliosis

Summary

The primary aim of this multicenter randomized controlled trial is to compare the effect of a 6 month "Schroth exercise program combined with standard-of-care" to "standard-of-care alone" on scoliosis curve severity measured using the Cobb angle.

Secondary aims include:

1. To determine the effect of Schroth exercises at 6 months on secondary outcomes including quality-of-life, spinal appearance, objective posture and spinal muscle endurance measurements.
2. To determine the efficacy of 6 months of Schroth therapy offered to control participants after completing 6 months in the standard-of care group (using subjects as their own controls)
3. To determine if the effects of the 6 months supervised Schroth exercise program can be maintained after supervised therapy is terminated.

At Hopital Ste-Justine, the following secondary aims will be pursued to examine the preliminary evidence about the effect of Global Postural Re-education (to satisfy the local ethics committee request because Global Postural Re-education exercises were offered routinely to patients at that institution prior to the trial).

A. To compare the effect and to quantify the treatment effect sizes of 6 months of "Global Postural Re-education exercises with North American standard Care consisting of only observation and bracing" to "Schroth exercises combined with North American standard care" and to "North American standard care alone" on scoliosis curve severity measured using the Cobb angle.

B. To estimate the effect and quantify the treatment effect sizes of 6 months of "Global Postural Re-education exercises with North American standard Care" to "Schroth exercises combined with North American standard care" and to "North American standard care alone" on outcomes including quality-of-life, perceived spinal appearance, objective posture and spinal muscle endurance measurements.

C. To determine if the effects of "Global Postural Re-education exercises with North American standard Care" can be maintained after discontinuing supervision.

D. To estimate the feasibility of conducting a randomized trial focused on Global Postural Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise sessions and compliance with the home exercises prescribed.

Conditions

• Scoliosis

Interventions

OTHER

The Schroth exercises treatment

The Schroth approach consists of 3D scoliosis-specific exercises based on sensorimotor and kinesthetic principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. To achieve this goal, Schroth exercises focus on endurance and strength training of postural muscles. Schroth exercises also aim to improve posture motor control by repeating corrective movements with progressively less feedback and less passive support. Dosage: 5 individual 1-hour long sessions, continued with the daily 45 minutes home exercise program. In addition, patients are required to come weekly for 1-hour long group sessions over the span of 6 months.

OTHER

Global Postural Re-Education

The 6-month supervised Global Postural Re-education intervention involves active movements and postures aimed at realigning joints, stretching shortened muscles and enhancing the contraction of antagonist muscles, thus avoiding postural asymmetry. These postures imply an active participation of the patient. Global Postural Re-education includes eight therapeutic postures, lying, sitting or standing, held for 15/20 min. each. Variously combinations are used during sessions chosen on based on the amount of pain, load capacity, age of the patient, and muscle chains to be stretched. Static and dynamic functions are also employed for about five minutes each sessions to use the recovered flexibility in functional activities Dosage: Weekly individual 1-hour long sessions, with daily 15 minutes home exercise program over 6 months.

Sponsors & Collaborators

• Glenrose Foundation

  collaborator OTHER

• Scoliosis Research Society

  collaborator OTHER

• SickKids Foundation CIHR Institute of Human Development, Child and Youth Health

  collaborator UNKNOWN

• University of Alberta

  lead OTHER

Principal Investigators

• Eric C Parent, PT, MSc, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

10 Years

Max Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2019-12-30

Completion

2020-12-30

Countries

• Canada

Study Locations