Musculoskeletal DiseasesNCT05696041
Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility
A study testing Static strength training program or/and Dynamic strength training program of the hand in people with Musculoskeletal Diseases and Joint Instability, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases, Joint Instability
- What is being tested?
- Static strength training program or/and Dynamic strength training program of the hand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2014to 31 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility -A Randomized Clinical Trial
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.
Read more
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.
Read the 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.
- Conditions
- Musculoskeletal Diseases, Joint Instability
- Being tested
- Static strength training program or/and Dynamic strength training program of the hand
- Keywords
- Therapeutics, Rehabilitation, Quality of Life
- Medical subject headings
- Musculoskeletal Diseases, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static strength training program or/and Dynamic strength training program of the handOther
Four of the five exercises included in the static or dynamic training program were based on holding the weight over the edge of the table and maintaining the position for 10 seconds, then resting briefly and changing to the next position. The training was performed in the following assumed positions, pronation, supination, radial and ulnar position. In the fifth and final exercise, you would squeeze an exercise ball as hard as possible without pain. The starting weight was 0.5 kilogram, and each exercise (1-4) was performed in three sets in the first week. The training increased by one set per week for up to eight sets/week if pain or paresthesia got worsened. If the training worked, the OT and the subject could choose to increase the weight to 1 kilogram and start over with three sets/day and gradually increase the training or switch to a dynamic training program.
| Study group | Role | What they receive |
|---|---|---|
| The exercise group (WSE) | Experimental | 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/hEDS
* Daily exercise
* Training schedule
* 3-4 return visits to the OT Receives: Other: Static strength training program or/and Dynamic strength training program of the hand |
| Conventional intervention (HO) | No intervention | * Prescribed the wrist´s with plastic or metal orthoses * Information about HSD/hEDS * Use the orthosis in specific activities; carrying, vacuuming, doing laundry, driving, bicycling * Training schedule * 3-4 return visits to the OT |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH questionnaire
A self-report instrument measuring capacity involving the shoulder arm and hand. The score is from 0-100 with 0 being no incapacities and 100 for the stated A change of more than 10 points on the DASH score as clinically significant.
Measured: Baseline 12 weeks 6 and 12 month
Secondary outcomes (3)
The EuroQol EQ-5D
A self-report measurement for health-related quality of life. The questionnaire consists of ranked increments from 1-3, where the person checks the option that best fits their current state of health. The second part consists score of perceived health status. A visual analogue scale, graded from 0-100.
Measured: Baseline 12 weeks 6 and 12 month
The Jamar dynamometer
Hand strength. Measured by the right and left hand three times. The Norm range score is based on numeric values for age and gender by North Coast TM Hand Dynamometer. Values below the reference values are considered reduced hand strength and values above the reference values are considered better than normal hand strength. The Norm Ranges differ for differing age intervals. Norm Ranges are also different for gender.
Measured: Baseline 12 weeks 6 and 12 month
The Grip Ability Test
Measure the function of the hand consisting of three sub-tasks. The reference value was numerical and had an average value of 16.5. A normal interval is considered between 11-20. Values above 20 indicate impaired hand function and values below 11 are considered above normal.
Measured: Baseline 12 weeks 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Aug 2014
- Primary completion31 Dec 2014
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696041
- Sponsor's protocol ID
- Gothenburg University
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility -A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05696041
- Acronym / sponsor ID
- Gothenburg University
- Conditions
- Musculoskeletal Diseases, Joint Instability
- Keywords
- Therapeutics, Rehabilitation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Aug 2014
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| The exercise group (WSE) | Experimental | Other: Static strength training program or/and Dynamic strength training program of the handInitial 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/hEDS * Daily exercise * Training schedule * 3-4 return visits to the OT |
| Conventional intervention (HO) | No intervention | –* Prescribed the wrist´s with plastic or metal orthoses * Information about HSD/hEDS * Use the orthosis in specific activities; carrying, vacuuming, doing laundry, driving, bicycling * Training schedule * 3-4 return visits to the OT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static strength training program or/and Dynamic strength training program of the handFour of the five exercises included in the static or dynamic training program were based on holding the weight over the edge of the table and maintaining the position for 10 seconds, then resting briefly and changing to the next position. The training was performed in the following assumed positions, pronation, supination, radial and ulnar position. In the fifth and final exercise, you would squeeze an exercise ball as hard as possible without pain. The starting weight was 0.5 kilogram, and each exercise (1-4) was performed in three sets in the first week. The training increased by one set per week for up to eight sets/week if pain or paresthesia got worsened. If the training worked, the OT and the subject could choose to increase the weight to 1 kilogram and start over with three sets/day and gradually increase the training or switch to a dynamic training program. | Other | The exercise group (WSE) |
Primary outcome
DASH questionnaire
Time frame: Baseline 12 weeks 6 and 12 month
A self-report instrument measuring capacity involving the shoulder arm and hand. The score is from 0-100 with 0 being no incapacities and 100 for the stated A change of more than 10 points on the DASH score as clinically significant.
3 secondary outcomes
The EuroQol EQ-5D
Time frame: Baseline 12 weeks 6 and 12 month
The Jamar dynamometer
Time frame: Baseline 12 weeks 6 and 12 month
The Grip Ability Test
Time frame: Baseline 12 weeks 6 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static strength training program or/and Dynamic strength training program of the hand in people with Musculoskeletal Diseases and Joint Instability, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH questionnaire (time frame: Baseline 12 weeks 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.