NCT02898558

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

September 8, 2016

Last Update Submit

November 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Rivermead Assessment of Somatosensory Performance

    Baseline, immediately after the training (two weeks) and after one month

  • Grip strength

    Baseline, immediately after the training (two weeks) and after one month

  • Finger tapping

    Baseline, immediately after the training (two weeks) and after one month

  • Reach and grasping

    Baseline, immediately after the training (two weeks) and after one month

Study Arms (1)

Magnification hand size

EXPERIMENTAL

magnifying lenses used for 30 minutes daily for 14 days while completing a jigsaw puzzle

Behavioral: Magnification hand sizeDevice: magnifying lenses

Interventions

Participants will use magnifying lenses while completing a jigsaw puzzle for 30 min a day for 14 days.

Magnification hand size
Magnification hand size

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from stroke who showed an improvement with magnifying lenses in our previous study.

You may not qualify if:

  • Patients suffering from stroke who did not show an improvement with magnifying lenses in our previous study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/s0960-9822(01)00327-x.

    PMID: 11516950BACKGROUND
  • 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.

    PMID: 14966526BACKGROUND
  • 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.

    PMID: 21303990BACKGROUND
  • 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.

    PMID: 17704352BACKGROUND
  • 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.

    PMID: 12194623BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Branch Coslett, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Steven Jax, PhD

    MOSS S.p.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share