An interventional study of Dynamic stability exercises in Hypermobility Syndrome and Hypermobile Ehlers-Danlos Syndrome, sponsored by University Hospital, Linkoeping. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Treatment
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.
The specific research questions are:
75 studies on the registry are indexed under Ehlers-Danlos Syndrome; 25 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 42 interventional studies indexed under Ehlers-Danlos Syndrome.
Browse Ehlers-Danlos Syndrome studies →University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.
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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.
A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
Behavioral: Dynamic stability exercises
A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
Identification of suitable measures for a forthcoming RCT
Qualitative and quantitative evaluation through secondaty outcome measures and qualitative interviews with patients and physiotherapists
Time frame: Nine months
Pain numeric rating scale
Rating of mean pain last week
Time frame: 6 months
Functional Rating Index
Disability regarding daily activities
Time frame: 6 months
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).
Time frame: 6 months
Arthritis Self-efficacy scale
Twenty items divided into three sub-scales for self-efficacy for physical function, other symptoms and pain.
Time frame: 6 months
Stress and Crisis Inventory-93
Thirty-five items on physical and psychological symptoms that can be clinical manifestations of stress.
Time frame: 6 months
Tampa Scale for Kinesiophobia
Questionnaire measuring kinesiophobia, 17 items.
Time frame: 6 months
Orthostatic Hypotension Questionnaire
Assessment of symptoms and daily activity in relation to orthostatic hypotension. 10 items.
Time frame: 6 months
European Quality of Life questionnaire (EQ-5D-3L)
Health related quality of life
Time frame: 6 months
Berg balance scale
14 tasks common in daily activities testing balance
Time frame: 6 months
Bruininks-Oseretsky Test of Motor Proficiency 2
Nine tasks testing balance
Time frame: 6 months
Timed up and go
Mobility, balance, walking ability and fall risk in older adults
Time frame: 6 months
2-minute walk test
Walking ability
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: Yes — Data is available from the authors on reasonable request.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Linkoeping