Parkinson DiseaseNCT05241015
Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients
A study testing Exercises Group in people with Parkinson Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
There are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in Parkinson's patients. According to the International Classification of Functioning, Disability and Health (ICF) model, there are restrictions on people's activities and participation in life due to… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercises Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2021to 20 Nov 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having idiopathic Parkinson's disease over the age of 40
- Meets the diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank
- Hoehn-Yahr Staging <3
- Mini mental test score of 24 and above
- In the "on" period
- Receiving oral therapy only
Who cannot join
- Patients receiving device-assisted therapy
- Patients receiving apomorphine therapy
- Patients with mini mental test scores below 24
- Patients who use drugs (antidepressants, etc.) that will affect cognitive functions
- Patients with hearing and speech problems
- Patients with orthopedic, neurological and vestibular problems other than Parkinson's that may prevent them from completing the tests and treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
Kayseri
About this study
Official title: Investigation of the Effect of Sensorimotor Training on Upper Extremity Functions, Activity and Participation in Parkinson's Patients
There are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in Parkinson's patients. According to the International Classification of Functioning, Disability and Health (ICF) model, there are restrictions on people's activities and participation in life due to structural and functional disorders affecting the upper extremity in PD.
In PD, integrating and using proprioceptive feedback, sensorimotor integration and peripheral sensory functions are reported to be impaired. Numerous studies show that the main source of motor problems in PD is dysfunction of sensorimotor integration. Since the cervical region contains a dense concentration of proprioceptive organs such as muscle spindles, it plays an important role in providing afferent proprioceptive information for postural control. Therefore, sensorimotor training targeting the cervical region gains importance. In this study, we aim to reduce PD-specific upper extremity disorders and related activity and participation limitations by increasing motor control in the cervical region with sensorimotor training. Patients with Parkinson's disease will be included in the study and randomly divided into 2 groups. While the general physiotherapy program will be applied to the control group, sensorimotor training will be given in addition to the exercise group.
- Conditions
- Parkinson Disease
- Being tested
- Control Group, Exercises Group
- Keywords
- Parkinson, Upper Extremity, Sensorimotor Training, ICF, Function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Treatment protocol; It will be applied to improve posture, strengthen muscles, eliminate shortness, increase flexibility, balance/coordination, sit up/stand up and in-bed mobilization, and improve gait. Before taking the treatment, a general evaluation will be made and as a result of this evaluation, muscle shortness, loss of strength, postural disorders and the activities and positions they have the most difficulty in daily life will be determined. Treatment programs will be shaped according to the problems determined in line with the evaluations made.
Exercises GroupOther
In addition to the standard physiotherapy program, sensorimotor training including the cervical region will be given to the this group. Deep cervical flexor and extensor muscles, which provide stability in the cervical region, will be trained. A Pressure Biofeedback Device will be used to train the deep cervical flexors. Both positional and kinesthetic sensory training will be provided by maintaining the stability of the cervical region by means of the laser kit that provides visual feedback.Additionally, oculomotor exercises will be given.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks. Receives: Other: Control Group |
| Exercises Group | Experimental | In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training. Receives: Other: Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture Analysis
New York Posture Rating Chart
Measured: Change from baseline at 8 week
Tremor
Fahn; Tolosa, Marin Clinical Tremor Rating Scale will be used to evaluate tremor. Each item was scored between 0-4. A lower score is an indicator of better status.
Measured: Change from baseline at 8 week
Unified Parkinson's Disease Rating Scale
Unified Parkinson's Disease Rating Scale is a scale that evaluates disability and disorders related to Parkinson's and consists of 4 main subtitles and 42 questions in total . Each item was scored between 0-4 . A lower score is an indicator of better status.
Measured: Change from baseline at 8 week
Proprioception
For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
Measured: Change from baseline at 8 week
Tactile acuity
For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
Measured: Change from baseline at 8 week
Touch threshold
Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
Measured: Change from baseline at 8 week
Pain threshold
Algometer will be used to evaluate upper extremity pain threshold.
Measured: Change from baseline at 8 week
Pain intensity
Visual pain scale (VAS) will be used to evaluate upper extremity pain.In the evaluation, pain averages ranging from 0 to 10 cm are given. "0" indicates that there is no pain, while as the score increases, the severity of pain increases.
Measured: Change from baseline at 8 week
Hand Grip Strength
Hand Dynamometer will be used to measure hand grip strength.
Measured: Change from baseline at 8 week
Pinch Grip Strength
Pinch meter will be used to measure pinch grip strength.
Measured: Change from baseline at 8 week
Endurance of Cervical Muscles
Craniocervical Flexion (CSF) test, Evaluation of cervical flexor-extensor muscles
Measured: Change from baseline at 8 week
Fatigue
Parkinson's Fatigue Scale will be used to evaluate fatigue. It is consists of 16 items related to presence of fatigue. All items are scored by patients using a five-point Likert-type scale including response options ranging from '(1) strongly disagree' to '(5) strongly agree'. A higher score indicates a higher level of fatigue.
Measured: Change from baseline at 8 week
Hand functions
Purdue Pegboard Test (PPT)
Measured: Change from baseline at 8 week
Dual Task Performance
During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.
Measured: Change from baseline at 8 week
Disabilities of the Arm, Shoulder and Hand Questionnaire
It will be used to determine the problems experienced in the use of the upper extremity. It consists of 3 sections. All questions are answered according to a 5-point Likert system. A score between 0-100 is obtained from each section. The higher the score, the higher the disability.
Measured: Change from baseline at 8 week
Quality of life evaluation
Parkinson's Disease Questionnaire (PDQ-39) will be used to evaluate quality of life. It contains 39 items in total. A score between 0 and 4 is given for each question. A high overall score indicates worsening quality of life.
Measured: Change from baseline at 8 week
Evaluation of Environmental Factors
Questions structured by the researchers will be used on the issues of support and attitudes under the environmental factors heading of the ICF model. Questions are scored between 0 and 10. A high score indicates high satisfaction.
Measured: Change from baseline at 8 week
Motor speed
Motor speed will be evaluated using the Finger tapping test.
Measured: Change from baseline at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start8 Dec 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University, Nuh Naci Yazgan University
- Responsible party
- Principal investigator, Ozlem Menevse, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241015
- Sponsor's protocol ID
- 2021/295 (Erciyes University)
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Sensorimotor Training on Upper Extremity Functions, Activity and Participation in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05241015
- Acronym / sponsor ID
- 2021/295 (Erciyes University)
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Upper Extremity, Sensorimotor Training, ICF, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University, Nuh Naci Yazgan University
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 15 Feb 2022 (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.
There are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in Parkinson's patients. According to the International Classification of Functioning, Disability and Health (ICF) model, there are restrictions on people's activities and participation in life due to structural and functional disorders affecting the upper extremity in PD.
In PD, integrating and using proprioceptive feedback, sensorimotor integration and peripheral sensory functions are reported to be impaired. Numerous studies show that the main source of motor problems in PD is dysfunction of sensorimotor integration. Since the cervical region contains a dense concentration of proprioceptive organs such as muscle spindles, it plays an important role in providing afferent proprioceptive information for postural control. Therefore, sensorimotor training targeting the cervical region gains importance. In this study, we aim to reduce PD-specific upper extremity disorders and related activity and participation limitations by increasing motor control in the cervical region with sensorimotor training. Patients with Parkinson's disease will be included in the study and randomly divided into 2 groups. While the general physiotherapy program will be applied to the control group, sensorimotor training will be given in addition to the exercise group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupPatients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks. |
| Exercises Group | Experimental | Other: Exercises GroupIn addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having idiopathic Parkinson's disease over the age of 40
- Meets the diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank
- Hoehn-Yahr Staging <3
- Mini mental test score of 24 and above
- In the "on" period
Key exclusion criteria (6 listed)
- Patients receiving device-assisted therapy
- Patients receiving apomorphine therapy
- Patients with mini mental test scores below 24
- Patients who use drugs (antidepressants, etc.) that will affect cognitive functions
- Patients with hearing and speech problems
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 |
|---|---|---|
| Control GroupTreatment protocol; It will be applied to improve posture, strengthen muscles, eliminate shortness, increase flexibility, balance/coordination, sit up/stand up and in-bed mobilization, and improve gait. Before taking the treatment, a general evaluation will be made and as a result of this evaluation, muscle shortness, loss of strength, postural disorders and the activities and positions they have the most difficulty in daily life will be determined. Treatment programs will be shaped according to the problems determined in line with the evaluations made. | Other | Control Group |
| Exercises GroupIn addition to the standard physiotherapy program, sensorimotor training including the cervical region will be given to the this group. Deep cervical flexor and extensor muscles, which provide stability in the cervical region, will be trained. A Pressure Biofeedback Device will be used to train the deep cervical flexors. Both positional and kinesthetic sensory training will be provided by maintaining the stability of the cervical region by means of the laser kit that provides visual feedback.Additionally, oculomotor exercises will be given. | Other | Exercises Group |
Primary outcome
Posture Analysis
Time frame: Change from baseline at 8 week
New York Posture Rating Chart
Tremor
Time frame: Change from baseline at 8 week
Fahn; Tolosa, Marin Clinical Tremor Rating Scale will be used to evaluate tremor. Each item was scored between 0-4. A lower score is an indicator of better status.
Unified Parkinson's Disease Rating Scale
Time frame: Change from baseline at 8 week
Unified Parkinson's Disease Rating Scale is a scale that evaluates disability and disorders related to Parkinson's and consists of 4 main subtitles and 42 questions in total . Each item was scored between 0-4 . A lower score is an indicator of better status.
Proprioception
Time frame: Change from baseline at 8 week
For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
Tactile acuity
Time frame: Change from baseline at 8 week
For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
Touch threshold
Time frame: Change from baseline at 8 week
Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
Pain threshold
Time frame: Change from baseline at 8 week
Algometer will be used to evaluate upper extremity pain threshold.
Pain intensity
Time frame: Change from baseline at 8 week
Visual pain scale (VAS) will be used to evaluate upper extremity pain.In the evaluation, pain averages ranging from 0 to 10 cm are given. "0" indicates that there is no pain, while as the score increases, the severity of pain increases.
Hand Grip Strength
Time frame: Change from baseline at 8 week
Hand Dynamometer will be used to measure hand grip strength.
Pinch Grip Strength
Time frame: Change from baseline at 8 week
Pinch meter will be used to measure pinch grip strength.
Endurance of Cervical Muscles
Time frame: Change from baseline at 8 week
Craniocervical Flexion (CSF) test, Evaluation of cervical flexor-extensor muscles
Fatigue
Time frame: Change from baseline at 8 week
Parkinson's Fatigue Scale will be used to evaluate fatigue. It is consists of 16 items related to presence of fatigue. All items are scored by patients using a five-point Likert-type scale including response options ranging from '(1) strongly disagree' to '(5) strongly agree'. A higher score indicates a higher level of fatigue.
Hand functions
Time frame: Change from baseline at 8 week
Purdue Pegboard Test (PPT)
Dual Task Performance
Time frame: Change from baseline at 8 week
During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.
Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: Change from baseline at 8 week
It will be used to determine the problems experienced in the use of the upper extremity. It consists of 3 sections. All questions are answered according to a 5-point Likert system. A score between 0-100 is obtained from each section. The higher the score, the higher the disability.
Quality of life evaluation
Time frame: Change from baseline at 8 week
Parkinson's Disease Questionnaire (PDQ-39) will be used to evaluate quality of life. It contains 39 items in total. A score between 0 and 4 is given for each question. A high overall score indicates worsening quality of life.
Evaluation of Environmental Factors
Time frame: Change from baseline at 8 week
Questions structured by the researchers will be used on the issues of support and attitudes under the environmental factors heading of the ICF model. Questions are scored between 0 and 10. A high score indicates high satisfaction.
Motor speed
Time frame: Change from baseline at 8 week
Motor speed will be evaluated using the Finger tapping test.
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 22 Feb 2024.
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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 Exercises Group in people with Parkinson Disease, run by Hacettepe 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 6 inclusion and 6 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 22 Feb 2024. 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?
Posture Analysis (time frame: Change from baseline at 8 week). The study lists 18 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 22 Feb 2024.