- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898558
Effect of Body Representation in Movement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Altering the apparent size of a body part with magnifying changes tactile acuity, tactile distance judgments and pain perception.
In a recent study we have tested if motor abilities (grip strength, finger tapping and reaching and grasping) of patients with stroke improve wearing magnifying lenses. The results of this study showed that a beneficial effect of magnifying lenses on movement can be observed in some patients with stroke. The present study aims at following up these results and investigating the possible use of magnifying lenses in the rehabilitation to improve motor controls of stroke patients.
To pursuit this aim, we will identify 12 patients in our previous study cohort who demonstrated an improvement greater than 10% in the grip strength or finger tapping task when wearing magnifying glasses. These participants will be invited to take part in the present clinical study in which they will undergo a training phase: subjects will wear magnifying lenses at home for 30 minutes daily for 14 days while completing a jigsaw puzzle; a log will be kept to document participation. Participants' performance on different motor tasks will be assessed before, immediately after and 1 month after the training session. Standardized measures of motor performance will include the the Action Research Arm test and the Rivermead Assessment of Somatosensory Performance (RASP). In addition, participants will undergo grip strength (6 trials), finger tapping tasks (6 trials) and a reaching and grasping task, inn which they will be asked to reach and grasp 3 different objects (30 trials). We expect the repeated use of magnifying lenses to generate an improvement of patients' performance across task and this effect to be persistent in time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients suffering from stroke who showed an improvement with magnifying lenses in our previous study.
Exclusion Criteria:
- Patients suffering from stroke who did not show an improvement with magnifying lenses in our previous study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Magnification hand size
magnifying lenses used for 30 minutes daily for 14 days while completing a jigsaw puzzle
|
Participants will use magnifying lenses while completing a jigsaw puzzle for 30 min a day for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm test
Time Frame: Baseline, immediately after the training (two weeks) and after one month
|
19 item measure of motor control (i.e.
(grasp, grip, pinch, and gross arm movement).
Max score is 57
|
Baseline, immediately after the training (two weeks) and after one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rivermead Assessment of Somatosensory Performance
Time Frame: Baseline, immediately after the training (two weeks) and after one month
|
Battery designed to test somatosensory functions, comprising of 7 subtests (sharp/dull discrimination, surface pressure touch, surface localization, sensory extinction, two-point discrimination, temperature discrimination, proprioception movement and direction discrimination).
Max score for each subtest is 60, except for sensory extinction (max is 12) and two-point discrimination (fail or pass).
|
Baseline, immediately after the training (two weeks) and after one month
|
|
Grip strength
Time Frame: Baseline, immediately after the training (two weeks) and after one month
|
A grip dynamometer measures participants' grip strength
|
Baseline, immediately after the training (two weeks) and after one month
|
|
Finger tapping
Time Frame: Baseline, immediately after the training (two weeks) and after one month
|
Electronic tapping test measures participants' tapping rate of the index finger
|
Baseline, immediately after the training (two weeks) and after one month
|
|
Reach and grasping
Time Frame: Baseline, immediately after the training (two weeks) and after one month
|
Motion tracking equipment used to measure participants kinematic parameters (movement time, peak velocity, grip aperture, etc.) when reaching and grasping 3 objects, for a total of 30 movements.
|
Baseline, immediately after the training (two weeks) and after one month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Branch Coslett, MD, University of Pennsylvania
- Study Director: Steven Jax, PhD, Moss
Publications and helpful links
General Publications
- Kennett S, Taylor-Clarke M, Haggard P. Noninformative vision improves the spatial resolution of touch in humans. Curr Biol. 2001 Aug 7;11(15):1188-91. doi: 10.1016/s0960-9822(01)00327-x.
- Taylor-Clarke M, Jacobsen P, Haggard P. Keeping the world a constant size: object constancy in human touch. Nat Neurosci. 2004 Mar;7(3):219-20. doi: 10.1038/nn1199. Epub 2004 Feb 15.
- Mancini F, Longo MR, Kammers MP, Haggard P. Visual distortion of body size modulates pain perception. Psychol Sci. 2011 Mar;22(3):325-30. doi: 10.1177/0956797611398496. Epub 2011 Feb 8.
- Yozbatiran N, Der-Yeghiaian L, Cramer SC. A standardized approach to performing the action research arm test. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):78-90. doi: 10.1177/1545968307305353. Epub 2007 Aug 17.
- Winward CE, Halligan PW, Wade DT. The Rivermead Assessment of Somatosensory Performance (RASP): standardization and reliability data. Clin Rehabil. 2002 Aug;16(5):523-33. doi: 10.1191/0269215502cr522oa.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 702940
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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