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NCT Number: NCT06698367

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

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.

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Key information

Conditions

Wrist Fractures Arm Injuries Behavior Distal Radius Fractures Fractures, Bone Motor Activity Wounds and Injuries Wrist Injuries

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Standard Rehabilitation

Other

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.

Unilateral high-intensity strength exercise

Other

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.

Unilateral mobility exercises

Other

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.

Primary outcomes

  1. Handgrip strength

    Time frame: 0, 6 and 12 weeks

    Jamar grip dynamometer (kilos)

  2. Manual dexterity

    Time frame: 0, 6 and 12 weeks

    Functional Dexterity Test (Seconds)

Secondary outcomes

  1. Active range motion

    Time frame: 0, 6 and 12 weeks

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

  2. Pain intensity

    Time frame: 0, 6 and 12 weeks

    Visual Analogue Scale (0-10 centimeters)

  3. Forearm circumference

    Time frame: 0, 6 and 12 weeks

    Circumference (cm)

  4. Maximum voluntary isometric strength.

    Time frame: 0, 6 and 12 weeks

    Progressor 300, Tindeq, Norway (Kilos)

  5. Self-reported upper limb function.

    Time frame: 0, 6 and 12 weeks

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

  6. Self-reported wrist function

    Time frame: 0, 6 and 12 weeks

    Patient-Rated Wrist Evaluation (0-50 points)

  7. Health-related quality of life

    Time frame: 0, 6 and 12

    Short Form-12 (0-100 points)

Other outcomes

  1. Depression, anxiety and stress

    Time frame: 0 week

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

  2. Treatment expectations

    Time frame: 0 week

    Treatment Expectation Questionnaire (0-10 points)

  3. Physical activity

    Time frame: 0 and 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Iván Cuyul Vásquez

CONTACT

[email protected]

56990914987

Sponsors and collaborators

Lead sponsor

Universidad Catolica de Temuco

Other

Registry information

Official study title

Addition of Unilateral Training of the Uninjured Limb to Standard Rehabilitation on Grip Strength and Manual Dexterity of Patients with Surgically Treated Distal Radius Fracture.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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