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Not yet recruitingNCT06698367Updated Dec 3, 2024

Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture

An interventional study of Standard rehabilitation and Unilateral high-intensity strength exercise in Wrist Fractures and Distal Radius Fractures, sponsored by Universidad Catolica de Temuco. Not yet recruiting at 1 site in Chile. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Universidad Catolica de Temuco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study summary

The objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. It is presumed that the addition of unilateral upper limb training will significantly improve maximum grip strength and manual dexterity at the end of the intervention period compared to the group receiving only standard rehabilitation.

Patients who agree to participate in this research will be randomly assigned to a control group (standard rehabilitation with unilateral training with mobility exercises) or an experimental group (standard rehabilitation with unilateral high-intensity strength training). The duration of the postoperative intervention will be 12 weeks. The primary variables are maximum grip strength and manual dexterity. Secondary variables are wrist mobility, forearm circumference, maximum voluntary isometric strength, functionality and health-related quality of life. Results will be measured at 0, 6 and 12 weeks postoperative.

02

Conditions studied

  • Wrist Fractures
  • Distal Radius Fractures

Keywords

  • Distal radius fracture
  • Cross-education
  • Rehabilitation
  • Exercise
03

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 30-50 years
  • Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.
  • Fracture treated surgically.

Exclusion criteria

Exclusion Criteria:

  • Patients with lesion of the triangular fibrocartilage.
  • Patients with distal radius fracture with consolidation disorders.
  • Patients with health conditions that cause pain or affect the motor skills of the upper limb (radiocarpal osteoarthritis, carpal tunnel syndrome, Quervain's tenosynovitis, neurodegenerative diseases, sequelae of stroke)
  • Patients with multi-site pain or chronic polyarticular diseases such as osteoarthritis or rheumatoid arthritis.
  • Unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow high-intensity physical exercise.
  • Patients who are taking nutritional supplements that interfere with the regulation of skeletal muscle strength and mass (example: whey protein, creatine, etc.)
  • Inability to understand, read and/or speak the Spanish language.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Standard rehabilitation plus unilateral high-intensity strength exercise

    Participants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation.

    Other: Standard rehabilitation · Other: Unilateral high-intensity strength exercise

  • Active comparator
    Standard rehabilitation plus unilateral mobility exercises

    Participants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation

    Other: Standard rehabilitation · Other: Unilateral mobility exercises

Interventions

  • OtherStandard rehabilitation

    Protocol based on the best available evidence and to be used in all participants in both groups. The standard rehabilitation protocol will consist of three postoperative phases: Mobilization (0 to 4 weeks), Strengthening (4 to 8 weeks) and Functional phase (8 to 12 weeks). Sessions will be held 3 times a week for 12 weeks. Each session will last 1 hour and will consist of different modalities of therapeutic exercise and cryotherapy.

  • OtherUnilateral high-intensity strength exercise

    Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an eccentric exercise for the pronosupinator muscles with a dumbbell with adjustable weights. The training will start with an intensity of 60% of 1RM, until reaching 80% 1RM.

  • OtherUnilateral mobility exercises

    Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an active mobility exercise for the pronation-supination muscles using a plastic rod.

05

What researchers measure

Primary outcomes

  1. Handgrip strength

    Jamar grip dynamometer (kilos)

    Time frame: 0, 6 and 12 weeks

  2. Manual dexterity

    Functional Dexterity Test (Seconds)

    Time frame: 0, 6 and 12 weeks

Secondary outcomes

  1. Active range motion

    Wrist and forearm: Extension, flexion, pronation and supination (degree)

    Time frame: 0, 6 and 12 weeks

  2. Pain intensity

    Visual Analogue Scale (0-10 centimeters)

    Time frame: 0, 6 and 12 weeks

  3. Forearm circumference

    Circumference (cm)

    Time frame: 0, 6 and 12 weeks

  4. Maximum voluntary isometric strength.

    Progressor 300, Tindeq, Norway (Kilos)

    Time frame: 0, 6 and 12 weeks

  5. Self-reported upper limb function.

    Quick Disabilities of Arm, Shoulder and Hand (0-100 points)

    Time frame: 0, 6 and 12 weeks

  6. Self-reported wrist function

    Patient-Rated Wrist Evaluation (0-50 points)

    Time frame: 0, 6 and 12 weeks

  7. Health-related quality of life

    Short Form-12 (0-100 points)

    Time frame: 0, 6 and 12

Other outcomes

  1. Depression, anxiety and stress

    Depression, Anxiety and Stress Scale (0-63 points)

    Time frame: 0 week

  2. Treatment expectations

    Treatment Expectation Questionnaire (0-10 points)

    Time frame: 0 week

  3. Physical activity

    International Physical Activity Questionnaire (Categorical Score: Low, Moderate. High)

    Time frame: 0 and 12 weeks

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06698367
Lead sponsor
Universidad Catolica de Temuco
Responsible party
Iván Alejandro Cuyul Vásquez (Principal Investigator, Universidad Catolica de Temuco) — Principal investigator
First posted
Nov 21, 2024
Start date
Jan 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Aug 2027 (estimated)
Last update
Dec 3, 2024

Study contacts

Iván Cuyul Vásquez
Contact
ivancuyul@gmail.com
56990914987

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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