Postoperative Rehabilitation or Mobilization After Scoliosis Surgery

NCT ID: NCT04403152

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-05
• Study Completion Date: 2017-11-15

Brief Summary

Scoliosis surgery is a major surgery associated with postoperative pain, loss of physical function and pulmonary dysfunction in adolescent idiopathic scoliosis patients (AIS).Despite the advanced, various medical treatment methods of pain applied in the postoperative period, the mean period of hospitalization is 5 to 7 days. The increasing health expenditures over the years have brought along the need for rehabilitation programs conducted in the early term. Although early mobilization has been accepted as a rule of thumb by spinal surgeons in preventing the performance loss and reducing the causes of morbidity in recent years, the investigators could not find any research on postoperative rehabilitation implemented on patients under the supervision of a physiotherapist, following scoliosis surgery. The aim of this study was to compare effect of five days of intensive postoperative rehabilitation and mobilization on length of hospitalization and outcome in patients having scoliosis surgery.

Detailed Description

Following spinal surgeries, patients experienced deep somatic pain and severe reflex spasms of the muscles located in the surgical site. In addition, pulmonary dysfunction could develop due to reduced flexibility of the spine and mobility of the ribs. It is a known fact that cardiopulmonary functions in adolescent idiopathic scoliosis patients may not recover even two years after surgery. After fusion surgeries in patients with scoliosis have shown that the static and dynamic postural control were impaired and that the postural control could recover one year after the surgery. The increasing health expenditures over the years have brought along the need for rehabilitation programs conducted in the early term.

Increased postoperative pain, impaired balance reactions in the short, weak EMG responses of the trunk muscles, decreased pulmonary capacity and increased health costs have necessitated early rehabilitation in patients who had undergone scoliosis surgery. Also, the need for further research on the effects of physiotherapeutic approaches on the aforementioned functional losses has been indicated in several studies.Although early mobilization has been accepted as a rule of thumb by spinal surgeons in preventing the performance loss and reducing the causes of morbidity in recent years, the investigators could not find any research on postoperative rehabilitation implemented on patients under the supervision of a physiotherapist, following scoliosis surgery.

Therefore, based on these findings, the aim of this study was to compare effect of five days of intensive postoperative rehabilitation and mobilization on length of hospitalization and outcome in patients having scoliosis surgery.

Conditions

Scoliosis Idiopathic; Scoliosis; Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitation group

This is the study group in whom post-operative rehabilitation was provided for 5 days.

Group Type: EXPERIMENTAL

Post-operative rehabilitation

Intervention Type: OTHER

Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.

Mobilization group

This is the control group in whom post-operative mobilization was provided for 5 days.

Group Type: ACTIVE_COMPARATOR

Post-operative mobilization

Intervention Type: OTHER

Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.

Interventions

Post-operative rehabilitation

Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.

Intervention Type: OTHER

Post-operative mobilization

Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.

Intervention Type: OTHER

Other Intervention Names

rehabilitation; mobilization

Eligibility Criteria

Inclusion Criteria

1. diagnosis of adolescent idiopathic scoliosis,

2. underwent posterior spinal fusion surgery,

3. Cobb's angle of 45 degrees or above,

4. were aged between 10 and 18 years.

Exclusion Criteria

1. diagnosis of neuromuscular or rheumatismal diseases,

2. could not comply with the exercise program,

3. severe surgery-related pulmonary complications

4. complications which would prevent early rehabilitation (such as postoperative cerebrospinal fluid leak, paraparesis, hemiparesis),

5. surgery-related wound infections.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Zilan Bazancir Apaydın

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Fatih Korkmaz, MD

Role: STUDY_DIRECTOR

Inonu University Faculy of Medicine

Locations

Zilan Bazancir Apaydın

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017/53

Identifier Type: -

Identifier Source: org_study_id