NCT04666896

Patient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability

Effectiveness of a 6-month Home-based Exercise Program for Treating Shoulder Instability in Patients With Hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): A Pilot Randomized Controlled Trial.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Consequently, evidence-based treatment approaches for the hEDS/HSD population are scarce. Therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.

Detailed description

The main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (MDI) in patients diagnosed with the hypermobile type of The Ehlers-Danlos syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD). Patients were randomly assigned to either the control group (B: evidence-based tailored care) or the experimental group (A: evidence-based standard care). Both groups received a home-based exercise program of 24 weeks. The primary outcome measure was the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH), Tampa Scale for Kinesiophobia (TSK), Patient-Specific Functional Scale (PSFS), Global Rating of Change (GROC), and pain pressure thresholds (PPTs). Outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).

Conditions

• Hypermobile Ehlers-Danlos Syndrome
• Hypermobility Syndrome
• Multidirectional Subluxation of Shoulder

Interventions

Type	Name	Description
OTHER	Tailored home-based exercise therapy	exercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides.
OTHER	Standard home-based exercise therapy	The exercise program consisted of 4 types of exercises for training 1) balance and proprioception; 2) isometric strength; 3) rotator cuff muscles; and 4) open chain elevation

Timeline

• Start date: 2019-05-09
• Primary completion: 2020-07-09
• Completion: 2020-07-09
• First posted: 2020-12-14
• Last updated: 2021-03-22

Locations

1 site across 1 country: Belgium