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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorUniversidad Catolica de Temuco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 30-50 years

Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.

Fracture treated surgically.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard rehabilitation

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Standard rehabilitation plus unilateral high-intensity strength exerciseExperimental treatment 2 interventions
Group B: Standard rehabilitation plus unilateral mobility exercisesActive comparator 2 interventions

Trial outcomes

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

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

Sponsors and contacts

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