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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02898558
Other study ID # 702940
Secondary ID
Status Completed
Phase N/A
First received September 8, 2016
Last updated November 28, 2017
Start date September 2016
Est. completion date September 2017

Study information

Verified date November 2017
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study explores the possible implications of the increase in perceived body size for rehabilitation of motor functions. In a recent study we have tested if motor abilities of patients with stroke improve wearing magnifying lenses, showing that a beneficial effect of magnifying lenses can be observed in some patients. In the present study, we will identify 12 patients from this cohort who demonstrated an improvement greater than 10% in one or two motor task when wearing magnifying glasses. These participants will be invited to take part in a 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, finger tapping tasks and a reaching and grasping task. We expect the repeated use of magnifying lenses to generate an improvement of patients' performance across tasks and this effect to be persistent in time.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Magnification hand size
Participants will use magnifying lenses while completing a jigsaw puzzle for 30 min a day for 14 days.
Device:
magnifying lenses


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Moss Rehabilitation Research Institute

References & Publications (5)

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. — View Citation

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. — View Citation

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. Epub 2004 Feb 15. — View Citation

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. — View Citation

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. Epub 2007 Aug 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Action Research Arm test 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 Rivermead Assessment of Somatosensory Performance 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
Secondary Grip strength A grip dynamometer measures participants' grip strength Baseline, immediately after the training (two weeks) and after one month
Secondary Finger tapping Electronic tapping test measures participants' tapping rate of the index finger Baseline, immediately after the training (two weeks) and after one month
Secondary Reach and grasping 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
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