HealthyNCT06766669
Adapting Shaping Activities Into Mirror Therapy
A study testing Shaping method activities combined with mirror therapy in people with Healthy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this case-control study is to assess the impact of a novel method which adapts shaping activities into mirror therapy to improve dexterity, reaction time, and motor learning of the non-dominant hand in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Shaping method activities combined with mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2024to 1 Sep 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-30 years old
- Dominant limb is right
Who cannot join
- A history of orthopedic disease, neurological disease, and/or surgery of the upper extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting Shaping Activities Into Mirror Therapy and Its Effects on Motor Dexterity, Motor Learning and Reaction Time in Healthy Individuals: A Case-Control Study
The goal of this case-control study is to assess the impact of a novel method which adapts shaping activities into mirror therapy to improve dexterity, reaction time, and motor learning of the non-dominant hand in healthy individuals. The main question it aims to answer is:
Does the use of Shaping Method as a protocol in Mirror Therapy will have an enhancing effect on upper extremity motor skills, motor learning and reaction time in healthy individuals.
Read more
The objective of this study is to compare the intervention group, which will undergo shaping method activities in accordance with the protocol set out in Mirror Therapy, with the control group. This will enable an assessment of the impact of this approach on dexterity, reaction time and motor learning of the non-dominant hand in healthy individuals.
Participants in intervention group will:
- Use the Shaping Method activities with mirror therapy for 4 weeks.
- Come to the exercise lab 2 times a week for 4 weeks.
- Participate in assessment tests at the beginning and end of the intervention period.
Participants in control group will:
- Take assessment tests twice, four weeks apart.
- Maintain their daily routine for the duration of their participation in the study.
Read the detailed description
In our study, 30 healthy adults were included in the intervention group and the same number of age- and gender-matched healthy adults were included in the control group.
The intervention group received 20-minute sessions, 2 days a week for 4 weeks. During the sessions, participants were seated with the non-dominant hand behind the mirror device and the dominant hand in front. The participants were instructed to perform the following exercises with their dominant hand for 10 repetitions in accordance with the Shaping Method: Clothespin attachment activity, Ring threading on rod, Connecting the dots, Putting pencils in the glass, Velcro board activity, Dipping fork in play dough activity, Placing the cubes in the box activity, Ball insertion into perforated plastic plate, The activity of touching colored paper placed between white papers, Geometric jigsaw activity. Participants were assessed with outcome measures before and at the end of the 4-week intervention period.
Participants in the control group received no intervention and were asked to continue their daily routines for 4 weeks. These participants were also assessed with outcome measures twice at 4-week intervals.
The SPSS 27.0 package program was used for statistical analysis. The normality of the distribution of quantitative variables was evaluated using the Shapiro-Wilk test. The demographic and clinical data were summarized as the mean ± standard deviation (SD) for the continuous variables and the number and percentage for the categorical variables. The initial measurements of the groups were compared using an independent samples t-test. A paired t-test was used to investigate intragroup differences between the pre- and post-tests. A one-way analysis of covariance (ANCOVA) was employed to determine the differences between the intervention and control groups, with baseline measurements serving as covariates. The differences between the groups were calculated based on the post-intervention assessment and the change from the pre-intervention values. The statistical significance was set to p< 0.05, and the effect sizes were interpreted as follows: ≤ 0.2, small; around 0.5, medium; ≥ 0.8, large.
- Conditions
- Healthy
- Being tested
- Shaping method activities combined with mirror therapy
- Keywords
- Mirror movement therapy, Motor activity, Motor skills, Reaction time
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shaping method activities combined with mirror therapyOther
This intervention involves the application of exercises consisting of shaping method activities accompanied by a mirror device. It is basically an intervention consisting of exercises that require manual dexterity.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy Group | Experimental | In this group, Shaping Method activities are added to Mirror Therapy as a protocol and applied to participants. Receives: Other: Shaping method activities combined with mirror therapy |
| Control Group | No intervention | The group that has no intervention and is asked to continue with their daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roeder Manipulative Aptitude Test
The Roeder Manipulative Aptitude Test, which involves the insertion of a rod, cap, washer, and nut-common field tools-into a perforated board, was employed to assess motor skills. The test is comprised of two phases, with a five-minute rest period between them. In the initial phase, which lasts three minutes, the subject is required to insert a rod and then a cap into the perforated sections with their non-dominant hand. The total number of rods and caps placed by the participant during this phase of the test is recorded as the unilateral score of the test. In the second stage of the test, which lasts 40 seconds, the participant places the nut and then the washer on the T-bar using both hands. At this juncture, the number of nuts and washers placed on the right and left sides is totaled and recorded as the bilateral score of the test. The sum of the unilateral and bilateral scores represents the total score of the test.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
Nelson Hand Reaction Time Test
This Test was employed to assess the participants' reaction time. During the test, the participant was seated in a chair and extended the non-dominant hand, with the thumb positioned opposite the other fingers, 8-10 cm away from the table. The initial point of a 50-centimeter-long ruler was held between the participant's thumb and index fingers, and the participant was instructed to fixate the center of the ruler. The researcher grasped the upper portion of the ruler and instructed the participant to "Ready!" before releasing the ruler. The participant was instructed to close their fingers as soon as possible in an attempt to catch the falling ruler. The test was repeated five times, with the two lowest scores being excluded. The arithmetic mean of the remaining three scores was then calculated.
Measured: From enrollment to the end of treatment at 4 weeks
Finger Tapping Test
The Finger Tapping Test was employed to assess motor learning. The test was created on the Psytoolkit online platform (https://www.psytoolkit.org). For the test, participants were seated in front of a laptop screen and instructed to place four fingers of their non-dominant hand (the fifth finger on the "1," the second finger on the "4") on the "1," "2," "3," and "4" keys on the keyboard. The subject was required to perform a series of keystrokes (4-1-3-2-4) that appeared on the screen for 10 seconds, as quickly and accurately as possible. The test was administered in 9 repetitions, with a 10-second rest interval between each repetition. The total number of sequences that the participant correctly keyed in 9 trials was recorded as the test score.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start26 Jul 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-Sectional, Case-Control Study Design
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burcu Ersöz Hüseyinsinoğlu, Associate Professor, Principal investigator, Marmara University, Department of Physiotherapy and RehabilitationÖzlem Doğan, Study chair, Marmara University, Department of Physiotherapy and RehabilitationAlime Nur Kara, Study chair, Marmara University, Department of Physiotherapy and RehabilitationSergen Öztürk, MSc, Study chair, Marmara University, Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766669
- Sponsor's protocol ID
- MarmaraU-FTR
- Other IDs
- 1919B012210132
- Status last verified
- Oct 2024
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jha RK, Thapa S, Kasti R, Nepal O. Influence of Body Mass Index, Handedness and Gender on Ruler Drop Method Reaction Time among Adults. J Nepal Health Res Counc. 2020 Apr 20;18(1):108-111. doi: 10.33314/jnhrc.v18i1.2545.
PubMed 32335603Aranha VP, Moitra M, Saxena S, Narkeesh K, Arumugam N, Samuel AJ. Motor cognitive processing speed estimation among the primary schoolchildren by deriving prediction formula: A cross-sectional study. J Neurosci Rural Pract. 2017 Jan-Mar;8(1):79-83. doi: 10.4103/0976-3147.193544.
PubMed 28149087Kesilmiş, İ., et al., Reaction Time in Target Shooting Sports: Perspective of Bocce and Archery. Eurasian Research in Sport Science, 2021. 6(2): p. 121-129.
Çakıt, E., B. Durgun, and M. Cetik, Assessing the Relationship Between Hand Dimensions and Manual Dexterity Performance for Turkish Dental Students. Vol. 489. 2016. 469-479.
Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.
PubMed 17039224
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Shaping Activities Into Mirror Therapy and Its Effects on Motor Dexterity, Motor Learning and Reaction Time in Healthy Individuals: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06766669
- Acronym / sponsor ID
- MarmaraU-FTR
- Conditions
- Healthy
- Keywords
- Mirror movement therapy, Motor activity, Motor skills, Reaction time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 Jan 2025 (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.
The goal of this case-control study is to assess the impact of a novel method which adapts shaping activities into mirror therapy to improve dexterity, reaction time, and motor learning of the non-dominant hand in healthy individuals. The main question it aims to answer is:
Does the use of Shaping Method as a protocol in Mirror Therapy will have an enhancing effect on upper extremity motor skills, motor learning and reaction time in healthy individuals.
The objective of this study is to compare the intervention group, which will undergo shaping method activities in accordance with the protocol set out in Mirror Therapy, with the control group. This will enable an assessment of the impact of this approach on dexterity, reaction time and motor learning of the non-dominant hand in healthy individuals.
Participants in intervention group will:
- Use the Shaping Method activities with mirror therapy for 4 weeks.
- Come to the exercise lab 2 times a week for 4 weeks.
- Participate in assessment tests at the beginning and end of the intervention period.
Participants in control group will:
- Take assessment tests twice, four weeks apart.
- Maintain their daily routine for the duration of their participation in the study.
Detailed description
In our study, 30 healthy adults were included in the intervention group and the same number of age- and gender-matched healthy adults were included in the control group.
The intervention group received 20-minute sessions, 2 days a week for 4 weeks. During the sessions, participants were seated with the non-dominant hand behind the mirror device and the dominant hand in front. The participants were instructed to perform the following exercises with their dominant hand for 10 repetitions in accordance with the Shaping Method: Clothespin attachment activity, Ring threading on rod, Connecting the dots, Putting pencils in the glass, Velcro board activity, Dipping fork in play dough activity, Placing the cubes in the box activity, Ball insertion into perforated plastic plate, The activity of touching colored paper placed between white papers, Geometric jigsaw activity. Participants were assessed with outcome measures before and at the end of the 4-week intervention period.
Participants in the control group received no intervention and were asked to continue their daily routines for 4 weeks. These participants were also assessed with outcome measures twice at 4-week intervals.
The SPSS 27.0 package program was used for statistical analysis. The normality of the distribution of quantitative variables was evaluated using the Shapiro-Wilk test. The demographic and clinical data were summarized as the mean ± standard deviation (SD) for the continuous variables and the number and percentage for the categorical variables. The initial measurements of the groups were compared using an independent samples t-test. A paired t-test was used to investigate intragroup differences between the pre- and post-tests. A one-way analysis of covariance (ANCOVA) was employed to determine the differences between the intervention and control groups, with baseline measurements serving as covariates. The differences between the groups were calculated based on the post-intervention assessment and the change from the pre-intervention values. The statistical significance was set to p< 0.05, and the effect sizes were interpreted as follows: ≤ 0.2, small; around 0.5, medium; ≥ 0.8, large.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-Sectional, Case-Control Study Design
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy Group | Experimental | Other: Shaping method activities combined with mirror therapyIn this group, Shaping Method activities are added to Mirror Therapy as a protocol and applied to participants. |
| Control Group | No intervention | –The group that has no intervention and is asked to continue with their daily routines. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18-30 years old
- Dominant limb is right
Key exclusion criteria (1 listed)
- A history of orthopedic disease, neurological disease, and/or surgery of the upper extremities
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 |
|---|---|---|
| Shaping method activities combined with mirror therapyThis intervention involves the application of exercises consisting of shaping method activities accompanied by a mirror device. It is basically an intervention consisting of exercises that require manual dexterity. | Other | Mirror Therapy Group |
Primary outcome
Roeder Manipulative Aptitude Test
Time frame: From enrollment to the end of treatment at 4 weeks
The Roeder Manipulative Aptitude Test, which involves the insertion of a rod, cap, washer, and nut-common field tools-into a perforated board, was employed to assess motor skills. The test is comprised of two phases, with a five-minute rest period between them. In the initial phase, which lasts three minutes, the subject is required to insert a rod and then a cap into the perforated sections with their non-dominant hand. The total number of rods and caps placed by the participant during this phase of the test is recorded as the unilateral score of the test. In the second stage of the test, which lasts 40 seconds, the participant places the nut and then the washer on the T-bar using both hands. At this juncture, the number of nuts and washers placed on the right and left sides is totaled and recorded as the bilateral score of the test. The sum of the unilateral and bilateral scores represents the total score of the test.
2 secondary outcomes
Nelson Hand Reaction Time Test
Time frame: From enrollment to the end of treatment at 4 weeks
Finger Tapping Test
Time frame: From enrollment to the end of treatment at 4 weeks
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 9 Jan 2025.
- Background: PubMed 32335603Jha RK, Thapa S, Kasti R, Nepal O. Influence of Body Mass Index, Handedness and Gender on Ruler Drop Method Reaction Time among Adults. J Nepal Health Res Counc. 2020 Apr 20;18(1):108-111. doi: 10.33314/jnhrc.v18i1.2545.
- Background: PubMed 28149087Aranha VP, Moitra M, Saxena S, Narkeesh K, Arumugam N, Samuel AJ. Motor cognitive processing speed estimation among the primary schoolchildren by deriving prediction formula: A cross-sectional study. J Neurosci Rural Pract. 2017 Jan-Mar;8(1):79-83. doi: 10.4103/0976-3147.193544.
- BackgroundKesilmiş, İ., et al., Reaction Time in Target Shooting Sports: Perspective of Bocce and Archery. Eurasian Research in Sport Science, 2021. 6(2): p. 121-129.
- BackgroundÇakıt, E., B. Durgun, and M. Cetik, Assessing the Relationship Between Hand Dimensions and Manual Dexterity Performance for Turkish Dental Students. Vol. 489. 2016. 469-479.
- Background: PubMed 17039224Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Burcu Ersöz Hüseyinsinoğlu, Associate Professor principal investigator
Marmara University, Department of Physiotherapy and Rehabilitation
Özlem Doğan study chair
Marmara University, Department of Physiotherapy and Rehabilitation
Alime Nur Kara study chair
Marmara University, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shaping method activities combined with mirror therapy in people with Healthy, run by Marmara University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 9 Jan 2025. 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 Turkey (Türkiye). 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?
Roeder Manipulative Aptitude Test (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766669, which also lists 5 linked publications.
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 9 Jan 2025.