HealthyNCT05988775
Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults
A study testing Leg training, Sequence observation and Nature movie watching in people with Healthy, run by Ariel University at 1 site in Israel.
Trial summary
To determine whether there is an ipsilateral transfer of motor skill from the lower to the upper limb in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Leg training, Sequence observation and Nature movie watching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 8 May 2022to 12 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 20 and 35
- right-hand dominant
- healthy according to self-report
Who cannot join
- musculoskeletal problems or any other problem that may interfere with the performance of the task (extension of an arm or leg while sitting).
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults: a Randomized Controlled Trial
To determine whether there is an ipsilateral transfer of motor skill from the lower to the upper limb in healthy adults.
Read the 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.
- Conditions
- Healthy
- Being tested
- Leg training, Sequence observation, Nature movie watching
- Keywords
- ipsilateral transfer, motor performance, lower limb, upper limb, reaching sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg trainingBehavioural
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 observationBehavioural
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
Nature movie watchingOther
Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
| Study group | Role | What they receive |
|---|---|---|
| Leg training | Experimental | 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. Receives: Behavioral: Leg training |
| Sequence observation | Active comparator | Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block. Receives: Behavioral: Sequence observation |
| Nature movie watching | Other | Participants watched a "scenic relaxation film," for 10 minutes, with a 30s break after every minute. Receives: Other: Nature movie watching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline - before the training session, post-test - immediately after the training session
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
Measured: 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
Average time of movements, measured from the time the switch lights up until it is pressed
Measured: baseline - before the training session, follow up - 24 hours after the training session
Secondary outcomes (3)
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.
Measured: baseline - before the training session, post-test - immediately after the training session
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.
Measured: post-test - immediately after the training session, follow up - 24 hours after the training session
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.
Measured: baseline - before the training session, follow up - 24 hours after the training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 May 2022
- Primary completion9 Mar 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvi Frenkel-Toledo, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988775
- Sponsor's protocol ID
- AU-HEA-OE-20210610
- Status last verified
- May 2022
- First submitted
- 30 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05988775
- Acronym / sponsor ID
- AU-HEA-OE-20210610
- Conditions
- Healthy
- Keywords
- ipsilateral transfer, motor performance, lower limb, upper limb, reaching sequence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether there is an ipsilateral transfer of motor skill from the lower to the upper limb in healthy adults.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Leg training | Experimental | Behavioral: Leg trainingParticipants 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 | Active comparator | Behavioral: Sequence observationParticipants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block. |
| Nature movie watching | Other | Other: Nature movie watchingParticipants watched a "scenic relaxation film," for 10 minutes, with a 30s break after every minute. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 20 and 35
- right-hand dominant
- healthy according to self-report
Key exclusion criteria (2 listed)
- musculoskeletal problems or any other problem that may interfere with the performance of the task (extension of an arm or leg while sitting).
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leg trainingParticipants 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. | Behavioural | Leg training |
| Sequence observationParticipants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block. | Behavioural | Sequence observation |
| Nature movie watchingParticipants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block. | Other | Nature movie watching |
Primary outcome
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
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
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
3 secondary outcomes
Change in failure (%) from baseline to post-test
Time frame: 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
Change in failure (%) from base line to follow up
Time frame: baseline - before the training session, follow up - 24 hours after the training session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvi Frenkel-Toledo, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg training, Sequence observation and Nature movie watching in people with Healthy, run by Ariel University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in response time (s) from baseline to post-test (time frame: baseline - before the training session, post-test - immediately after the training session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.