HealthyNCT05748769
Ipsilateral Transfer of Motor Skill From Upper to Lower Limb in Healthy Adults
A study testing Practice (UL), Observation (SO) and Nature Observation (NO) in people with Healthy, run by Ariel University at 1 site in Israel.
Trial summary
To determine whether there is an ipsilateral transfer of a motor skill from the upper limb to the lower limb 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?
- Practice (UL), Observation (SO) and Nature Observation (NO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Jan 2022to Sep 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
- Healthy (self report)
- right hand dominant
Who cannot join
- musculoskeletal or neurological deficits interfering with task performance (proper upper limb and lower limb reaching performance)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ipsilateral Transfer of Motor Skill From Upper to Lower Limb in Healthy Adults: a Randomized Controlled Trial
To determine whether there is an ipsilateral transfer of a motor skill from the upper limb to the lower limb
Read the detailed description
In a single-blind randomized controlled study, 60 healthy subjects randomly participated in one of three single-session interventions: (1) Practicing reaching movement (RM) sequences with the non-dominant left upper limb towards illuminating switches (UL group); (2) Observing the identical sequences of the illuminating switches (Switches Observation (SO) group); and (3) Observing nature movies (Nature Observation (NO) group). Subjects participated in two sessions. The first session included familiarization practice of the motor task, a pretest, a single session intervention (according to group randomization), and a posttest. The second session included a retest, 24 hours after the training.
Recording apparatus used in tests (pretest, posttest, and retest): 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 toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded.
For testing the leg performance, subjects sat on a custom-designed plinth with a solid back support in front of the apparatus at the same height as the tabletop, hence they could perform the RM sequence with the leg. At the starting position, the heel was placed on the edge of the table in front of switch 3, so when the left heel touched switch 3, the knee reached 30° flexion.
Training conditions: In each of the UL, SO, and NO groups, a 16-minute single-session intervention was conducted. The initial testing position of the subjects during the intervention was sitting on a chair with solid back support, hips, and knees flexed 90°, in front of the apparatus used for the tests. The starting position of the UL group was placing the left fist on the edge of the table in front of the subject's chest (parallel to switch 3) so that they could reach and touch switch 3 with their third left metacarpal. The UL group was instructed to reach with the left UL from the starting position as fast and accurately as possible to the illuminating switch, press it, and return to the starting position, while the fist must remain in contact with the table. They were not notified about the sequence. The subjects performed RMs toward the units that were activated in the same order as the tested sequence 1-4-3-5-4-2, and with an activation duration and delay of 1 s. The practice included 16 blocks, each consisting of 30 RM with a 30 s pause after each block (Fig. 1b). The SO group was instructed to observe the illuminating switches while avoiding moving. The subjects observed RMs toward the units that were activated in the same order as the practiced sequence 1-4-3-5-4-2, also with an activation duration and delay of 1 s and 30 s pause after each block. The NO group was instructed to observe a video clip while avoiding moving. The video clip consisted of a 16 min nature movie in cycles of one-minute observation and pausing 30 s, equivalent to the timing of RMs performed by groups UL and SO.
- Conditions
- Healthy
- Being tested
- Practice (UL), Observation (SO), Nature Observation (NO)
- Keywords
- ipsilateral transfer, motor performance, Upper limb, Lower limb, reaching sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice (UL)Behavioural
Subjects performed RMs toward the units that were activated in the same order as the tested sequence 1-4-3-5-4-2, and with an activation duration and delay of 1 s. The practice included 16 blocks, each consisting of 30 RM with a 30 s pause after each block
Observation (SO)Behavioural
Subjects observed the illuminating switches while avoiding moving. The subjects observed RMs toward the units that were activated in the same order as the practiced sequence 1-4-3-5-4-2, also with an activation duration and delay of 1 s and 30 s pause after each block.
Nature Observation (NO)Behavioural
The video-clip consisted of a 16 min nature movie in cycles of one-minute observation and pausing 30 s, equivalent to the timing of RMs performed by groups UL and SO
| Study group | Role | What they receive |
|---|---|---|
| UL group | Experimental | SIngle session of practicing RM sequence with the UL towards illuminating switches Receives: Behavioral: Practice (UL) |
| Switches observation - SO group | Active comparator | Single session of observation of sequence of illuminating switches Receives: Behavioral: Observation (SO) |
| (Nature observation -NO group | Active comparator | Single session of observation of nature movies Receives: Behavioral: Nature Observation (NO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Time (msec.)
Change in response time (msec.) from pretest to posttest. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded. Improved motor performance was indicated by a shorter Response Time
Measured: Pretest - before the training session, posttest - immediately after the training session
Response Time (msec.)
Change in response time (msec.) from posttest to retest. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded. Improved motor performance was indicated by a shorter Response Time
Measured: Posttest - immediately after the training session, retest - 24 hours after the training session
Response Time (msec.)
Change in response time (msec.) from pretest to retest. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded. Improved motor performance was indicated by a shorter Response Time
Measured: Pretest - before the training session, retest - 24 hours after the training session
Secondary outcomes (3)
% of fails
Change in the % of fails from pretest to posttest. Fails were considered when touching the activated unit-related switch within 1 s. Improved motor performance was indicated by a lower % of fails
Measured: Pretest - before the training session, posttest - immediately after the training session
% of fails
Change in the % of fails from posttest to retest. Fails were considered when touching the activated unit-related switch within 1 s. Improved motor performance was indicated by a lower % of fails
Measured: Posttest - immediately after the training session, retest - 24 hours after the training session
% of fails
Change in the % of fails from pretest to retest. Fails were considered when touching the activated unit-related switch within 1 s. Improved motor performance was indicated by a lower % of fails
Measured: Pretest - before the training session, retest - 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 posted1 Mar 2023
- Study start17 Jan 2022
- Primary completion20 Sep 2022
- Study completionSep 2023 (estimated)
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 control trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748769
- Sponsor's protocol ID
- AU-HEA-OE-20210610-B
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 29 Mar 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 upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ipsilateral Transfer of Motor Skill From Upper to Lower Limb in Healthy Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05748769
- Acronym / sponsor ID
- AU-HEA-OE-20210610-B
- Conditions
- Healthy
- Keywords
- ipsilateral transfer, motor performance, Upper limb, Lower limb, reaching sequence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 1 Mar 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 a motor skill from the upper limb to the lower limb
Detailed description
In a single-blind randomized controlled study, 60 healthy subjects randomly participated in one of three single-session interventions: (1) Practicing reaching movement (RM) sequences with the non-dominant left upper limb towards illuminating switches (UL group); (2) Observing the identical sequences of the illuminating switches (Switches Observation (SO) group); and (3) Observing nature movies (Nature Observation (NO) group). Subjects participated in two sessions. The first session included familiarization practice of the motor task, a pretest, a single session intervention (according to group randomization), and a posttest. The second session included a retest, 24 hours after the training.
Recording apparatus used in tests (pretest, posttest, and retest): 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 toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded.
For testing the leg performance, subjects sat on a custom-designed plinth with a solid back support in front of the apparatus at the same height as the tabletop, hence they could perform the RM sequence with the leg. At the starting position, the heel was placed on the edge of the table in front of switch 3, so when the left heel touched switch 3, the knee reached 30° flexion.
Training conditions: In each of the UL, SO, and NO groups, a 16-minute single-session intervention was conducted. The initial testing position of the subjects during the intervention was sitting on a chair with solid back support, hips, and knees flexed 90°, in front of the apparatus used for the tests. The starting position of the UL group was placing the left fist on the edge of the table in front of the subject's chest (parallel to switch 3) so that they could reach and touch switch 3 with their third left metacarpal. The UL group was instructed to reach with the left UL from the starting position as fast and accurately as possible to the illuminating switch, press it, and return to the starting position, while the fist must remain in contact with the table. They were not notified about the sequence. The subjects performed RMs toward the units that were activated in the same order as the tested sequence 1-4-3-5-4-2, and with an activation duration and delay of 1 s. The practice included 16 blocks, each consisting of 30 RM with a 30 s pause after each block (Fig. 1b). The SO group was instructed to observe the illuminating switches while avoiding moving. The subjects observed RMs toward the units that were activated in the same order as the practiced sequence 1-4-3-5-4-2, also with an activation duration and delay of 1 s and 30 s pause after each block. The NO group was instructed to observe a video clip while avoiding moving. The video clip consisted of a 16 min nature movie in cycles of one-minute observation and pausing 30 s, equivalent to the timing of RMs performed by groups UL and SO.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized control trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| UL group | Experimental | Behavioral: Practice (UL)SIngle session of practicing RM sequence with the UL towards illuminating switches |
| Switches observation - SO group | Active comparator | Behavioral: Observation (SO)Single session of observation of sequence of illuminating switches |
| (Nature observation -NO group | Active comparator | Behavioral: Nature Observation (NO)Single session of observation of nature movies |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy (self report)
- right hand dominant
Key exclusion criteria (1 listed)
- musculoskeletal or neurological deficits interfering with task performance (proper upper limb and lower limb reaching performance)
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 |
|---|---|---|
| Practice (UL)Subjects performed RMs toward the units that were activated in the same order as the tested sequence 1-4-3-5-4-2, and with an activation duration and delay of 1 s. The practice included 16 blocks, each consisting of 30 RM with a 30 s pause after each block | Behavioural | UL group |
| Observation (SO)Subjects observed the illuminating switches while avoiding moving. The subjects observed RMs toward the units that were activated in the same order as the practiced sequence 1-4-3-5-4-2, also with an activation duration and delay of 1 s and 30 s pause after each block. | Behavioural | Switches observation - SO group |
| Nature Observation (NO)The video-clip consisted of a 16 min nature movie in cycles of one-minute observation and pausing 30 s, equivalent to the timing of RMs performed by groups UL and SO | Behavioural | (Nature observation -NO group |
Primary outcome
Response Time (msec.)
Time frame: Pretest - before the training session, posttest - immediately after the training session
Change in response time (msec.) from pretest to posttest. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded. Improved motor performance was indicated by a shorter Response Time
Response Time (msec.)
Time frame: Posttest - immediately after the training session, retest - 24 hours after the training session
Change in response time (msec.) from posttest to retest. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded. Improved motor performance was indicated by a shorter Response Time
Response Time (msec.)
Time frame: Pretest - before the training session, retest - 24 hours after the training session
Change in response time (msec.) from pretest to retest. Activation of a specific unit LED was a cue for the subject to reach toward that unit and press the push-button switch. Reaching toward the switch of an activated unit deactivated it, and the response time, between the activated and deactivated LED, was recorded. Improved motor performance was indicated by a shorter Response Time
3 secondary outcomes
% of fails
Time frame: Pretest - before the training session, posttest - immediately after the training session
% of fails
Time frame: Posttest - immediately after the training session, retest - 24 hours after the training session
% of fails
Time frame: Pretest - before the training session, retest - 24 hours after the training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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 upon 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice (UL), Observation (SO) and Nature Observation (NO) 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?
Results are not available in the source record.
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?
Response Time (msec.) (time frame: Pretest - before the training session, posttest - 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 29 Mar 2023.