Hypermobile Ehlers-Danlos Syndrome Clinical Trial
Official title:
Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder - a Mixed-methods Feasibility Study
NCT number | NCT05800262 |
Other study ID # | 1A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 19, 2019 |
Est. completion date | December 12, 2019 |
Verified date | March 2023 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Symptomatic hypermobility may lead to a number of restrictions in daily life. So far, there is a lack of effective treatments. A whole-body dynamic stability exercise intervention targets to stimulate the dynamic stability and activation of the proprioceptive system and thereby intends to improve patients' health. The aim of the current study was to examine the feasibility, acceptability and impact of a whole-body dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder. The aim of the current study was to examine the feasibility, acceptability and impact of a dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder. Methods: This is a mixed-methods feasibility study. Fifteen patients (14 women and 1 man) with hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder and chronic pain were recruited from two pain specialist clinics in the South-East of Sweden. A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks. Patient reported outcome measures (PROMs) included pain and function, psychological well-being and quality of life. The clinical tests included walking and balance. Through qualitative interviews patients and physiotherapists described their experiences of the assessments and intervention. Assessments were done at baseline, after the intervention, and at the 3-month follow-up.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 12, 2019 |
Est. primary completion date | September 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility | Inclusion Criteria: Inclusion criteria were adults aged 18 to 67 years old, with generalized hypermobility (castori. A framework), persistent pain (i.e. longer than three months) in at least two of four quadrants of the body and ability to perform the exercises. Exclusion Criteria: Exclusion criteria were cancer-related pain, underlying neurological disease, presence of severe psychiatric disorders, known substance abuse, patients in the process of finding optimal medication as well as patients with previous experience of similar exercises. |
Country | Name | City | State |
---|---|---|---|
Sweden | Pain and rehabilitation center, University Hospital of Linkoping. | Linköping | Östergötland |
Sweden | Samrehab Smärtenheten, the Hospital of Västervik | Västervik | Kalmar Län |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping | Länssjukhuset i Kalmar län, Linkoeping University, Medical Research Council of Southeast Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of suitable measures for a forthcoming RCT | Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists | Nine months | |
Secondary | Pain numeric rating scale | Rating of mean pain last week | 6 months | |
Secondary | Functional Rating Index | Disability regarding daily activities | 6 months | |
Secondary | Multidimensional Fatigue Inventory 20 | Five subscales measuring general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue.
Item 19 was removed according to Hagelin (2009). |
6 months | |
Secondary | Arthritis Self-efficacy scale | Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain. | 6 months | |
Secondary | Stress and Crisis Inventory-93 | Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress. | 6 months | |
Secondary | Tampa Scale for Kinesiophobia | Questionnaire measuring kinesiophobia, 17 items. | 6 months | |
Secondary | Orthostatic Hypotension Questionnaire | Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items. | 6 months | |
Secondary | European Quality of Life questionnaire (EQ-5D-3L) | Health related quality of life | 6 months | |
Secondary | Berg balance scale | 14 tasks common in daily activities testing balance | 6 months | |
Secondary | Bruininks-Oseretsky Test of Motor Proficiency 2 | Nine tasks testing balance | 6 months | |
Secondary | Timed up and go | Mobility, balance, walking ability and fall risk in older adults | 6 months | |
Secondary | 2-minute walk test | Walking ability | 6 months | |
Secondary | Wii balance test using a Wii Balance Board | Balance test. Centre of pressure path length, anterio-posterior and medio-lateral sway measured standing on two feet with eyes open and eyes closed, standing on dominant foot and on non-dominant foot with eyes open. Tests performed according to Schmidt (2017), but during 60 seconds instead of 30 seconds. | 6 months |
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