Postoperative Rehabilitation or Mobilization After Scoliosis Surgery

NCT04403152 | Completed

• 1 other identifier: 2017/53
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic; Scoliosis; Adolescence

Keywords

rehabilitation; post-operative; early ambulation; posterior fusion surgery

Outcome Measures

Primary Outcomes (2)

• Pain via Visual Analogue Scale

  Change from baseline at 1 week Pain of the patients will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Patients is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 1 week of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.

  Baseline, 1 week

• Thoracic Mobility Index

  Change from baseline at 1 week Thoracic mobility index was measured at the axillar, epigastric and subcostal regions during normal, maximal inspiration and maximal expiration, using a tape measure, baseline,1 week of follow-ups.

  Baseline, 1 week

Secondary Outcomes (3)

• Trunk Balance Test

  Baseline, 1 week

• 2-minute Walking Test (2MWT)

  Baseline, 1 week

• Scoliosis Research Society-22 (SRS-22)

  Baseline, 6 week

Study Arms (2)

Rehabilitation group

EXPERIMENTAL

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

Other: Post-operative rehabilitation

Mobilization group

ACTIVE COMPARATOR

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

Other: Post-operative mobilization

Interventions

Post-operative rehabilitation OTHER

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

Also known as: rehabilitation

Rehabilitation group

Post-operative mobilization OTHER

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

Also known as: mobilization

Mobilization group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of adolescent idiopathic scoliosis,
• underwent posterior spinal fusion surgery,
• Cobb's angle of 45 degrees or above,
• were aged between 10 and 18 years.

You may not qualify if:

• diagnosis of neuromuscular or rheumatismal diseases,
• could not comply with the exercise program,
• severe surgery-related pulmonary complications
• complications which would prevent early rehabilitation (such as postoperative cerebrospinal fluid leak, paraparesis, hemiparesis),
• surgery-related wound infections.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Zilan Bazancir Apaydın

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mehmet Fatih Korkmaz, MD

  Inonu University Faculy of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: February 5, 2017
• Primary Completion: October 20, 2017
• Study Completion: November 15, 2017
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 12 months after publication
• Access Criteria: Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,

Locations

TU (1)