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Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility

Primary Purpose

Musculoskeletal Diseases, Joint Instability

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Static strength training program or/and Dynamic strength training program of the hand
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring Therapeutics, Rehabilitation, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gothenburg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The exercise group (WSE)

Conventional intervention (HO)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 5, 2023
Last Updated
January 23, 2023
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT05696041
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (undefined)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
January 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases, Joint Instability
Keywords
Therapeutics, Rehabilitation, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Clinical Trial
Masking
ParticipantCare Provider
Masking Description
Subjects were data randomized to the intervention group or control group in the order in which the signed consent forms were received. Occupational therapy in the Primary Care received information, training, and a manual with study protocols on procedures and the names of the included subjects, approximately three weeks before the start of studies. Neither OTs nor participants knew which intervention the subjects were randomized to until the envelopes were opened.
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The exercise group (WSE)
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional intervention (HO)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Static strength training program or/and Dynamic strength training program of the hand
Intervention Description
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.
Primary Outcome Measure Information:
Title
DASH questionnaire
Description
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.
Time Frame
Baseline 12 weeks 6 and 12 month
Secondary Outcome Measure Information:
Title
The EuroQol EQ-5D
Description
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.
Time Frame
Baseline 12 weeks 6 and 12 month
Title
The Jamar dynamometer
Description
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.
Time Frame
Baseline 12 weeks 6 and 12 month
Title
The Grip Ability Test
Description
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.
Time Frame
Baseline 12 weeks 6 and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gothenburg University
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility

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