Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05988775
Other study ID # AU-HEA-OE-20210610
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 8, 2022
Est. completion date March 12, 2023

Study information

Verified date May 2022
Source Ariel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine whether there is an ipsilateral transfer of motor skill from the lower to the upper limb in healthy adults.


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: 1. "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. 2. "Sequence observation" Participants observed 10 blocks of the identical sequence with the lights alternating automatically, with a 30s break between each block. 3. "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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date March 12, 2023
Est. primary completion date March 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Sequence observation
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
Other:
Nature movie watching
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.

Locations

Country Name City State
Israel Ariel University Ariel

Sponsors (1)

Lead Sponsor Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in response time (s) from baseline to post-test 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
Primary Change in response time (s) from post-test to follow up 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
Primary Change in response time (s) from baseline to follow up 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 Change in failure (%) from baseline to post-test 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
Secondary Change in failure (%) from post-test to follow up 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
Secondary Change in failure (%) from base line to follow up 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1