Wrist Stabilizing Exercise Versus Hand Orthotic Intervention for Persons With Hypermobility

NCT05696041 | Completed DMC

• 1 other identifier: Gothenburg University
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Diseases; Joint Instability

Keywords

Therapeutics; Rehabilitation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline 12 weeks 6 and 12 month

Secondary Outcomes (3)

• The EuroQol EQ-5D

  Baseline 12 weeks 6 and 12 month

• The Jamar dynamometer

  Baseline 12 weeks 6 and 12 month

• The Grip Ability Test

  Baseline 12 weeks 6 and 12 month

Study Arms (2)

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

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

Interventions

Static strength training program or/and Dynamic strength training program of the hand OTHER

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.

The exercise group (WSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Gothenburg University

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized Clinical Trial

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 25, 2023
• Study Start: August 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: January 31, 2016
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)