Distal Radius Fracture
Conditions
Keywords
Distal radius fracture, Motor imagery, Immobilisation, Effectivity
Brief summary
The aim of this study is to determine whether motor imagery training during the immobilisation period in patients with a distal radius fracture, results in an improved functional outcome compared to patients who do not perform motor imagery.
Detailed description
Rationale: Distal radius fracture (DRF) is a common injury that may lead to prolonged function restrictions, decreased range of motion, reduced grip strength and pain. These symptoms may be caused by physical changes due to the injury and/or by the 4-6 weeks immobilization that is part of the conservative treatment. However, it might also be that neural changes during the immobilization play an important role. Such changes might be prevented by motor imagery training during the immobilization period. So, when neural changes are prevented, this may lead to a better functional outcome. Objective: The objective is to improve the functional outcome in distal radius fracture patients, specified as an increase in function, dexterity, grip strength, range of motion, and decrease of pain. Study design: Parallel group randomized controlled trial, with a post-test only control group design. Patients in the experimental group perform motor imagery training during the immobilization period, in addition to the regular treatment. Patients in the control group receive regular treatment. Study population: Female DRF-patients who are conservatively treated by a cast, aged 45-75 years. The fracture must be a low energy trauma caused by a fall. Patients with a score higher than 72 on the Vividness of Motor Imagery Questionnaire (VMIQ) are excluded, as well as patients with co-morbidities that might influence the wrist function, or motor imagery-ability, and patients with no understanding of Dutch language. The patients are randomly allocated to the experimental or control group by restricted randomization to ensure equal group sizes. Intervention: Motor imagery training during the immobilization period). Main study parameters/endpoints: The main study parameter is function. Secondary study parameters are dexterity, range of motion, grip strength, and pain.
Interventions
BEHAVIORALMotor imagery
The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* female patients * non-comminutive distal radius fracture * 45 to 75 years of age
Exclusion criteria
* distal radius fracture caused by HET * comorbidities possibly influencing wrist function * comorbidities possibly influencing motor imagery ability * score higher than 72 on the Vividness of Motor Imagery Questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Function | 2 days after cast removal | Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dexterity | Directly after cast removal | Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale). The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996). The SODA consists of 12 tasks, and it takes 20 minutes to complete it. The performance on the tasks is scored by the experimenter. The score for each task is build up by two different components. One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task. For some tasks, only one hand is scored, while for other tasks both hands are scored. The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996). |
| Current Pain Level | Directly after cast removal | Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) |
| Pain Relief | Directly after cast removal | Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) |
| Grip Strength (Difference Unaffected - Affected) | 2 weeks after cast removal | Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms. Grip and pinch strength of the non-affected hand were measured as reference. The averages of three measurements were used in all analyses. |
| Hand Function | 2 weeks after cast removal | Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function) |
| Grip Strength | Directly after cast removal | Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms. Grip and pinch strength of the non-affected hand were measured as reference. The averages of three measurements were used in all analyses. |
| Range of Motion | Directly after cast removal. | Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom). ROM of the non-affected hand was also measured as reference. |
Countries
Netherlands
Participant flow
Recruitment details
Recruited through invitation letter after ER visit. Recruitment took place between July 2011 and January 2020
Pre-assignment details
Out of 117 patients, 3 did not respond to the invitation and 42 responded that they did not want to participate
Participants by arm
| Arm | Count |
|---|---|
| Control Patients allocated to the control group only receive standard treatment. | 19 |
| Motor Imagery Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period.
Motor imagery: The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist. | 24 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 6 |
| Overall Study | Logistic error | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | VMIQ score > 72 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 7 |
Baseline characteristics
| Characteristic | Control | Motor Imagery | Total |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 6.7 | 58.7 years STANDARD_DEVIATION 7.5 | 58.7 years STANDARD_DEVIATION 7.1 |
| AO classification 23A | 14 Participants | 16 Participants | 30 Participants |
| AO classification 23B | 2 Participants | 2 Participants | 4 Participants |
| AO classification 23C | 3 Participants | 6 Participants | 9 Participants |
| Dominant hand affected | 10 Participants | 18 Participants | 28 Participants |
| Fracture type (extra-articular) | 16 Participants | 18 Participants | 34 Participants |
| Hand dominance Left | 2 Participants | 3 Participants | 5 Participants |
| Hand dominance Right | 17 Participants | 21 Participants | 38 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Netherlands | 19 participants | 24 participants | 43 participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 24 |
| other Total, other adverse events | 0 / 19 | 0 / 24 |
| serious Total, serious adverse events | 0 / 19 | 1 / 24 |
Outcome results
Primary
Hand Function
Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function)
Time frame: 2 days after cast removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Hand Function | 44.3 score on a scale | Standard Deviation 19.4 |
| Motor Imagery | Hand Function | 48.0 score on a scale | Standard Deviation 23.2 |
Other Pre-specified
Current Pain Level
Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)
Time frame: Directly after cast removal
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Current Pain Level | 10.0 score on a scale |
| Motor Imagery | Current Pain Level | 4.0 score on a scale |
Other Pre-specified
Current Pain Level
Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)
Time frame: 2 weeks after cast removal
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Current Pain Level | 9.0 score on a scale |
| Motor Imagery | Current Pain Level | 8.5 score on a scale |
Other Pre-specified
Dexterity
Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale). The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996). The SODA consists of 12 tasks, and it takes 20 minutes to complete it. The performance on the tasks is scored by the experimenter. The score for each task is build up by two different components. One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task. For some tasks, only one hand is scored, while for other tasks both hands are scored. The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996).
Time frame: 2 weeks after cast removal
Population: Some participants dropped out between T1 and T2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Dexterity | 102.0 points |
| Motor Imagery | Dexterity | 99.5 points |
Other Pre-specified
Dexterity
Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale). The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996). The SODA consists of 12 tasks, and it takes 20 minutes to complete it. The performance on the tasks is scored by the experimenter. The score for each task is build up by two different components. One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task. For some tasks, only one hand is scored, while for other tasks both hands are scored. The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996).
Time frame: Directly after cast removal
Population: Not all patients were able to perform the tasks of the SODA, explaining lower number of participants included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Dexterity | 87.5 score on a scale |
| Motor Imagery | Dexterity | 88.0 score on a scale |
Other Pre-specified
Grip Strength
Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms. Grip and pinch strength of the non-affected hand were measured as reference. The averages of three measurements were used in all analyses.
Time frame: Directly after cast removal
Population: Not all participants were able to perform the grips or pinch movements requested, explaining why some outcome measures have less patients included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Grip Strength | Key pinch | 2.9 kg | Standard Deviation 1.3 |
| Control | Grip Strength | Power grip | 15.6 kg | Standard Deviation 3.6 |
| Control | Grip Strength | Three-jaw pinch | 3.4 kg | Standard Deviation 1.2 |
| Control | Grip Strength | Two-point pinch | 1.9 kg | Standard Deviation 0.9 |
| Motor Imagery | Grip Strength | Two-point pinch | 2.2 kg | Standard Deviation 1 |
| Motor Imagery | Grip Strength | Three-jaw pinch | 3.6 kg | Standard Deviation 1.7 |
| Motor Imagery | Grip Strength | Power grip | 15.2 kg | Standard Deviation 5.7 |
| Motor Imagery | Grip Strength | Key pinch | 2.6 kg | Standard Deviation 1.2 |
Other Pre-specified
Grip Strength (Difference Unaffected - Affected)
Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms. Grip and pinch strength of the non-affected hand were measured as reference. The averages of three measurements were used in all analyses.
Time frame: 2 weeks after cast removal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Grip Strength (Difference Unaffected - Affected) | Power grip | 11.5 kg | Standard Deviation 5 |
| Control | Grip Strength (Difference Unaffected - Affected) | Key pinch | 2.2 kg | Standard Deviation 1.5 |
| Control | Grip Strength (Difference Unaffected - Affected) | Three-jaw pinch | 2.4 kg | Standard Deviation 1.5 |
| Control | Grip Strength (Difference Unaffected - Affected) | Two-point pinch | 1.4 kg | Standard Deviation 1.1 |
| Motor Imagery | Grip Strength (Difference Unaffected - Affected) | Two-point pinch | 1.0 kg | Standard Deviation 1.2 |
| Motor Imagery | Grip Strength (Difference Unaffected - Affected) | Power grip | 10.5 kg | Standard Deviation 5.8 |
| Motor Imagery | Grip Strength (Difference Unaffected - Affected) | Three-jaw pinch | 2.2 kg | Standard Deviation 1.4 |
| Motor Imagery | Grip Strength (Difference Unaffected - Affected) | Key pinch | 1.7 kg | Standard Deviation 1.2 |
Other Pre-specified
Hand Function
Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function)
Time frame: 2 weeks after cast removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Hand Function | 32.4 score on a scale | Standard Deviation 19.2 |
| Motor Imagery | Hand Function | 35.3 score on a scale | Standard Deviation 20.7 |
Other Pre-specified
Pain Relief
Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)
Time frame: Directly after cast removal
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Pain Relief | 69.0 score on a scale |
| Motor Imagery | Pain Relief | 78.0 score on a scale |
Other Pre-specified
Pain Relief
Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)
Time frame: 2 weeks after cast removal
Population: Some participants dropped out between T1 and T2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Pain Relief | 67.0 score on a scale |
| Motor Imagery | Pain Relief | 81.5 score on a scale |
Other Pre-specified
Range of Motion
Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom). ROM of the non-affected hand was also measured as reference.
Time frame: Directly after cast removal.
Population: Some participants could not do all movements, which explains that some ROMs have a lower number of participants in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Range of Motion | Extension | 34.7 degrees | Standard Deviation 13.8 |
| Control | Range of Motion | Flexion | 39.0 degrees | Standard Deviation 12.2 |
| Control | Range of Motion | Pronation | 8.3 degrees | Standard Deviation 19.8 |
| Control | Range of Motion | Supination | 24.3 degrees | Standard Deviation 21.5 |
| Control | Range of Motion | Radial deviation | 5.9 degrees | Standard Deviation 6.6 |
| Control | Range of Motion | Ulnar deviation | 8.5 degrees | Standard Deviation 6.2 |
| Motor Imagery | Range of Motion | Radial deviation | 7.1 degrees | Standard Deviation 7.5 |
| Motor Imagery | Range of Motion | Extension | 25.7 degrees | Standard Deviation 17.3 |
| Motor Imagery | Range of Motion | Supination | 26.4 degrees | Standard Deviation 25.7 |
| Motor Imagery | Range of Motion | Flexion | 35.8 degrees | Standard Deviation 20.6 |
| Motor Imagery | Range of Motion | Ulnar deviation | 13.0 degrees | Standard Deviation 8.1 |
| Motor Imagery | Range of Motion | Pronation | 11.5 degrees | Standard Deviation 14 |
Other Pre-specified
Range of Motion
Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom). ROM of the non-affected hand was also measured as reference.
Time frame: 2 weeks after cast removal.
Population: Some participants could not do all movements, which explains that some ROMs have a lower number of participants in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Range of Motion | Extension | 18.1 degrees | Standard Deviation 15.9 |
| Control | Range of Motion | Flexion | 16.2 degrees | Standard Deviation 21.6 |
| Control | Range of Motion | Pronation | 4.4 degrees | Standard Deviation 11.9 |
| Control | Range of Motion | Supination | 17.5 degrees | Standard Deviation 21.9 |
| Control | Range of Motion | Radial deviation | 2.7 degrees | Standard Deviation 5.4 |
| Control | Range of Motion | Ulnar deviation | 9.3 degrees | Standard Deviation 6.3 |
| Motor Imagery | Range of Motion | Radial deviation | 4.4 degrees | Standard Deviation 6.7 |
| Motor Imagery | Range of Motion | Extension | 14.3 degrees | Standard Deviation 13 |
| Motor Imagery | Range of Motion | Supination | 20.5 degrees | Standard Deviation 23 |
| Motor Imagery | Range of Motion | Flexion | 21.5 degrees | Standard Deviation 15.3 |
| Motor Imagery | Range of Motion | Ulnar deviation | 8.0 degrees | Standard Deviation 7.9 |
| Motor Imagery | Range of Motion | Pronation | 2.5 degrees | Standard Deviation 13.2 |