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

NCT04666896 | Terminated

• 2 other identifiers: B670201939864BOF17/DOC/220
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Hypermobile Ehlers-Danlos syndrome; Hypermobility Spectrum Disorder; Mutlidirectional shoulder instability; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario Shoulder Instability Index (WOSI)

  The WOSI is a responsive patient-reported and disease-specific tool, designed to be used as the primary outcome measure in clinical trials that assess treatments for patients with shoulder instability. Range 0 - 2100 points. Higher scores express worse status.

  Measured at baseline, 6 weeks, 12 weeks and 24 weeks, in order to assess the change in WOSI from baseline to 6 weeks, 12 weeks, and 24 weeks

Secondary Outcomes (5)

• The Disabilities of the Arm Shoulder and Hand (DASH)

  Measured at baseline, 6 weeks, 12 weeks and 24 weeks

• The Tampa Scale for Kinesiophobia (TSK)

  Measured at baseline, 6 weeks, 12 weeks and 24 weeks

• The Patient-Specific Functional Scale (PSFS)

  Measured at baseline, 6 weeks, 12 weeks and 24 weeks

• The Global Rating of Change (GROC)

  Measured at baseline, 6 weeks, 12 weeks and 24 weeks

• Pain pressure thresholds (PPT)

  Measured at baseline, 6 weeks, 12 weeks and 24 weeks

Study Arms (2)

Evidence-based tailored care (group A)

EXPERIMENTAL

Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data.

Other: Tailored home-based exercise therapy

Evidence-based standard care (group B)

ACTIVE COMPARATOR

This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format.

Other: Standard home-based exercise therapy

Interventions

Tailored home-based exercise therapy OTHER

exercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides.

Evidence-based tailored care (group A)

Standard home-based exercise therapy OTHER

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

Evidence-based standard care (group B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Gender 'female' on ID (passport)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years
• Patients diagnosed by a medical doctor with generalized HSD or hEDS, according to the diagnostic criteria for hEDS and HSD as stated in the recently published international classification for the Ehlers-Danlos syndromes
• Patients diagnosed with multidirctional shoulder instability (MDI): The diagnosis of MDI was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, Gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study.

You may not qualify if:

• pregnancy during study participation
• patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University, department of rehabilitation sciences

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3

Study Officials

• Fransiska Malfait, Prof. Dr.

  Centre of Medical Genetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: May 9, 2019
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

BE (1)