Clinical trial NCT05696041: Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility
Official title: Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility -A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Joint Instability
Keywords: Therapeutics
Rehabilitation
Quality of Life
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: The goal of this study is to investigate if a Wrist Stabilizing Exercise Programme, WSE, compared to Conventional Intervention use of orthosis in daily activities, HO in persons with Hypermobility Spectrum Disorders, HSD or hypermobility Ehlers Danlos Syndrome, hEDS, in order to reduce pain and or paraesthesia in the hand.

Participants are persons with HSD and hEDS with symptoms of persistent or intermittent pain and or paraesthesia in the hands for the past three years.

The main question aims to answer

* if the WSE has effect on occupational performance and health related quality of life
* if the WSE has effect on handfunction and handstrength The intervention WSE aimed to improve wrist stabilization and increased grip strength according to a training program.

Researchers will compare WSE and HO to see if there were changes between and within the intervention group, WSE and Convention group.

Detailed description: HSD and hEDS involves connective tissue and is characterized by hypermobility, pain and skin manifestations.

It is unknown whether persons with HSD and hEDS suffer from pain and or paraesthesia in the hands, which contributes to impaired hand function and grip strength, and it is unknown how it affects work performance and health-related quality of life. The purpose of the study was to investigate the effect of wrist stabilizing exercises WSE compared to conventional intervention HO, including orthosis, in persons with HSD and hEDS in order to reduce pain and or paraesthesia in the hand. In addition, the study examined how the interventions affected occupational performance and health-related quality of life as well as effects on function and strength.

Method The samples consisted of adults with HSD and hEDS with symptoms of persistent or intermittent pain and or paraesthesia in the hands for the past three years. WSE aimed at better wrist stabilization and increased grip strength according to a training program. The HO groups intervention included a hand orthosis during daily activities. The study examined changes between and within the interventions of WSE and HO over 12 weeks.169 subjects agreed to participate in the study and were randomized to WSE n = 83 or HO n = 86.

Measurements at baseline, after the end of the intervention and after 6 and 12 months.

The intervention WSE consited of Initial static strength training program for the wrist, which could progress to a higher weight in kilos alternatively to a dynamic strength training program. Information about HSD and hEDS. Daily exercise. Training schedule. 3-4 return visits to the OT.

The conventional HO Prescribed the wrist´s with plastic or metal orthoses. Information about HSD and hEDS. Use the orthosis in specific activities; carrying, vacuuming, doing laundry, driving, bicycling. Training schedule. 3-4 return visits to the OT.

Measurement instruments; JAMAR dynamometer, Disability arm, shoulder and hand Dash, Grip Ability Test GAT, EQ5D.

Approximately 20-25 Occupational Terapists OT with experience of hand training attended a half-day training session and were informed about the study design. The OTs were given a manual for conducting the study. The manual contained information on how the study protocol was to be handled and documented and how the information was to be presented to the subjects. The OTs were trained in the use and administration of the assessment instruments.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years and older
* The diagnosis of HSD/hEDS within the last three years, with intermittent or consistent pain, and/or paresthesia of the hand.
* Swedish speaking

Exclusion Criteria:

* Another illness/injury, such as stroke or arm/hand fracture/injury during the past 6 months, combined with HSD/hEDS, which could have affected the study's results.

Primary outcomes:
measure: DASH questionnaire
timeFrame: Baseline 12 weeks 6 and 12 month
Secondary outcomes:
measure: The EuroQol EQ-5D
timeFrame: Baseline 12 weeks 6 and 12 month
measure: The Jamar dynamometer
timeFrame: Baseline 12 weeks 6 and 12 month
measure: The Grip Ability Test
timeFrame: Baseline 12 weeks 6 and 12 month
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburg University
Study officials:
References: