- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988775
Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults
Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a single-blind randomized controlled study,45 healthy subjects were randomly allocated to one of three single intervention groups: (1) "Leg Training" group (LT) (15 participants) practiced reaching movement (RM) sequences with the non-dominant left lower limb towards the numbered illuminating switch; (2) "Sequence observation" group (SO) (15 participants) observed the identical sequences of the illuminating switches (Switches Observation (SO) group); and (3) "Nature Movie Watching" (MW) group. (15 participants) watched a neutral nature video. Each subject was asked to attend two consecutive sessions, day after day. The first session included familiarization practice of the motor task, a pretest, a single session intervention (according to group randomization), and a posttest. Subjects participated in two sessions. The second session included a retest, 24 hours after the training. The predefined sequence consisted of six reaching movements in the following order of switches: 1, 4, 3, 5, 4, 2.
Recording apparatus used in tests (pretest, posttest, and retest) and training: A custom-made testing device was set up on a rectangular table with a smooth laminated tabletop of 105 cm × 80 cm and adjustable height. Five switch-led units of 5 cm × 8 cm × 5 cm, each composed of a large push-button switch and a red light-emitting diode (LED), attached to the tabletop in a 38-cm radius half circle, successively numbered from 1 to 5. The system was operated by a desktop computer, interfaced with a data acquisition card of LABVIEW software. The algorithm allowed parameters selection of LED activation (illumination) sequence, duration of RM, the delay between RMs, and the number of RM repetitions. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded.
Tests (motor tasks): The non-dominant left arm was tested. Motor task: The subjects performed a sequential movement task on a table with push button switches with lights sequentially turning on to indicate the order. Each switch lit up for 1 second, or until hit. Initially, the participants were required to perform 3 sequences to familiarize themselves with the setup, the task, and the sequence. Then, they performed the pre-test which consisted of two blocks of 5 sequences, i.e. 10 sequences, with a 30s break between blocks. After this, the participants underwent one of the following predetermined interventions groups:
- "Leg Training" Participants sat on a chair with their left heel resting on the table with the push button switches. They performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.
- "Sequence observation" Participants observed 10 blocks of the identical sequence with the lights alternating automatically, with a 30s break between each block.
- "Nature movie watching" Participants watched a "scenic relaxation film" for 10 minutes, with a 30s break after every minute.
Two outcome measures were used: 1. response time (s), 2. failure (%) of the reaching movements, defined as failure to reach the switch in the allotted time (1 sec), or pressing the wrong buzzer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ariel, Israel
- Ariel University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged between 20 and 35
- right-hand dominant
- healthy according to self-report
Exclusion Criteria:
- musculoskeletal problems or any other problem that may interfere with the performance of the task (extension of an arm or leg while sitting).
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Leg training
Participants sat on a chair with their left heel resting on the table with the push button switches.
participants performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.
|
Participants sat on a chair with their left heel resting on the table with the push button switches.
participants performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.
|
Active Comparator: Sequence observation
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
|
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
|
Other: Nature movie watching
Participants watched a "scenic relaxation film," for 10 minutes, with a 30s break after every minute.
|
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in response time (s) from baseline to post-test
Time Frame: baseline - before the training session, post-test - immediately after the training session
|
Average time of movements, measured from the time the switch lights up until it is pressed
|
baseline - before the training session, post-test - immediately after the training session
|
Change in response time (s) from post-test to follow up
Time Frame: post-test - immediately after the training session, follow up - 24 hours after the training session
|
Average time of movements, measured from the time the switch lights up until it is pressed
|
post-test - immediately after the training session, follow up - 24 hours after the training session
|
Change in response time (s) from baseline to follow up
Time Frame: baseline - before the training session, follow up - 24 hours after the training session
|
Average time of movements, measured from the time the switch lights up until it is pressed
|
baseline - before the training session, follow up - 24 hours after the training session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in failure (%) from baseline to post-test
Time Frame: baseline - before the training session, post-test - immediately after the training session
|
Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.
|
baseline - before the training session, post-test - immediately after the training session
|
Change in failure (%) from post-test to follow up
Time Frame: post-test - immediately after the training session, follow up - 24 hours after the training session
|
Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.
|
post-test - immediately after the training session, follow up - 24 hours after the training session
|
Change in failure (%) from base line to follow up
Time Frame: baseline - before the training session, follow up - 24 hours after the training session
|
Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.
|
baseline - before the training session, follow up - 24 hours after the training session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Silvi Frenkel-Toledo, PhD, Study Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- AU-HEA-OE-20210610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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