Trial Outcomes & Findings for Motor Imagery in Rehabilitation After a Distal Radius Fracture (NCT NCT01921062)

NCT ID: NCT01921062

Last Updated: 2024-02-21

Results Overview

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)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 2 days after cast removal
• Results posted on: 2024-02-21

Participant Flow

Recruited through invitation letter after ER visit. Recruitment took place between July 2011 and January 2020

Out of 117 patients, 3 did not respond to the invitation and 42 responded that they did not want to participate

Participant milestones

Measure	Control Patients allocated to the control group only receive standard treatment.	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.
Overall Study STARTED	28	38
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Measure	Control Patients allocated to the control group only receive standard treatment.	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.
Overall Study Withdrawal by Subject	0	7
Overall Study Adverse Event	5	6
Overall Study Protocol Violation	0	1
Overall Study VMIQ score > 72	4	1
Overall Study Logistic error	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=24 Participants 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.	Total n=43 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 6.7 • n=19 Participants	58.7 years STANDARD_DEVIATION 7.5 • n=24 Participants	58.7 years STANDARD_DEVIATION 7.1 • n=43 Participants
Sex: Female, Male Female	19 Participants n=19 Participants	24 Participants n=24 Participants	43 Participants n=43 Participants
Sex: Female, Male Male	0 Participants n=19 Participants	0 Participants n=24 Participants	0 Participants n=43 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	19 participants n=19 Participants	24 participants n=24 Participants	43 participants n=43 Participants
Fracture type (extra-articular)	16 Participants n=19 Participants	18 Participants n=24 Participants	34 Participants n=43 Participants
AO classification 23A	14 Participants n=19 Participants	16 Participants n=24 Participants	30 Participants n=43 Participants
AO classification 23B	2 Participants n=19 Participants	2 Participants n=24 Participants	4 Participants n=43 Participants
AO classification 23C	3 Participants n=19 Participants	6 Participants n=24 Participants	9 Participants n=43 Participants
Dominant hand affected	10 Participants n=19 Participants	18 Participants n=24 Participants	28 Participants n=43 Participants
Hand dominance Right	17 Participants n=19 Participants	21 Participants n=24 Participants	38 Participants n=43 Participants
Hand dominance Left	2 Participants n=19 Participants	3 Participants n=24 Participants	5 Participants n=43 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Control n=15 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=20 Participants 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.
Hand Function	44.3 score on a scale Standard Deviation 19.4	48.0 score on a scale Standard Deviation 23.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=22 Participants 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.
Grip Strength (Difference Unaffected - Affected) Power grip	11.5 kg Standard Deviation 5.0	10.5 kg Standard Deviation 5.8
Grip Strength (Difference Unaffected - Affected) Key pinch	2.2 kg Standard Deviation 1.5	1.7 kg Standard Deviation 1.2
Grip Strength (Difference Unaffected - Affected) Three-jaw pinch	2.4 kg Standard Deviation 1.5	2.2 kg Standard Deviation 1.4
Grip Strength (Difference Unaffected - Affected) Two-point pinch	1.4 kg Standard Deviation 1.1	1.0 kg Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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).

Outcome measures

Measure	Control n=17 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=16 Participants 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.
Dexterity	87.5 score on a scale Interval 72.3 to 92.0	88.0 score on a scale Interval 77.0 to 95.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Directly after cast removal

Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=23 Participants 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.
Current Pain Level	10.0 score on a scale Interval 2.5 to 23.5	4.0 score on a scale Interval 2.0 to 18.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Directly after cast removal

Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=23 Participants 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.
Pain Relief	69.0 score on a scale Interval 48.0 to 90.5	78.0 score on a scale Interval 49.0 to 90.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Measure	Control n=21 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=19 Participants 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.
Range of Motion Extension	34.7 degrees Standard Deviation 13.8	25.7 degrees Standard Deviation 17.3
Range of Motion Flexion	39.0 degrees Standard Deviation 12.2	35.8 degrees Standard Deviation 20.6
Range of Motion Pronation	8.3 degrees Standard Deviation 19.8	11.5 degrees Standard Deviation 14.0
Range of Motion Supination	24.3 degrees Standard Deviation 21.5	26.4 degrees Standard Deviation 25.7
Range of Motion Radial deviation	5.9 degrees Standard Deviation 6.6	7.1 degrees Standard Deviation 7.5
Range of Motion Ulnar deviation	8.5 degrees Standard Deviation 6.2	13.0 degrees Standard Deviation 8.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=20 Participants 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.
Hand Function	32.4 score on a scale Standard Deviation 19.2	35.3 score on a scale Standard Deviation 20.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Measure	Control n=18 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=21 Participants 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.
Grip Strength Power grip	15.6 kg Standard Deviation 3.6	15.2 kg Standard Deviation 5.7
Grip Strength Key pinch	2.9 kg Standard Deviation 1.3	2.6 kg Standard Deviation 1.2
Grip Strength Three-jaw pinch	3.4 kg Standard Deviation 1.2	3.6 kg Standard Deviation 1.7
Grip Strength Two-point pinch	1.9 kg Standard Deviation 0.9	2.2 kg Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks after cast removal

Population: Some participants dropped out between T1 and T2

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).

Outcome measures

Measure	Control n=15 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=18 Participants 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.
Dexterity	102.0 points Interval 97.5 to 103.5	99.5 points Interval 92.3 to 105.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks after cast removal

Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=22 Participants 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.
Current Pain Level	9.0 score on a scale Interval 3.0 to 13.5	8.5 score on a scale Interval 3.3 to 15.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks after cast removal

Population: Some participants dropped out between T1 and T2

Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=22 Participants 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.
Pain Relief	67.0 score on a scale Interval 35.0 to 81.0	81.5 score on a scale Interval 37.0 to 86.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Measure	Control n=19 Participants Patients allocated to the control group only receive standard treatment.	Motor Imagery n=22 Participants 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.
Range of Motion Extension	18.1 degrees Standard Deviation 15.9	14.3 degrees Standard Deviation 13.0
Range of Motion Flexion	16.2 degrees Standard Deviation 21.6	21.5 degrees Standard Deviation 15.3
Range of Motion Pronation	4.4 degrees Standard Deviation 11.9	2.5 degrees Standard Deviation 13.2
Range of Motion Supination	17.5 degrees Standard Deviation 21.9	20.5 degrees Standard Deviation 23.0
Range of Motion Radial deviation	2.7 degrees Standard Deviation 5.4	4.4 degrees Standard Deviation 6.7
Range of Motion Ulnar deviation	9.3 degrees Standard Deviation 6.3	8.0 degrees Standard Deviation 7.9

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Motor Imagery

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=19 participants at risk Patients allocated to the control group only receive standard treatment.	Motor Imagery n=24 participants at risk 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.
Musculoskeletal and connective tissue disorders Non-fusion of conservatively treated distal radius fracture	0.00% 0/19 • 2 months Non-fusion of a fracture after 5 weeks of immobilisation	4.2% 1/24 • 2 months Non-fusion of a fracture after 5 weeks of immobilisation

Other adverse events

Adverse event data not reported

Additional Information

Dieuwke Broekstra, PhD; postdoctoral researcher

University Medical Center Groningen

Phone: 0031503613531

Email: d.c.broekstra@umcg.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place