Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)NCT04673838
The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
A study testing neurodevelopmental therapy and Lower extremity sensory training in people with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of our study is to assess the effect of lower limb sensory training on proprioception, balance, gait and motor functions in Hemiparetic Individuals. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
- What is being tested?
- neurodevelopmental therapy and Lower extremity sensory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 20 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 20-65 and discharged from the hospital,
- Having been diagnosed with hemiparesis at least 4 weeks ago,
- First time and one-sided hemiparesis,
- Modified Rankin Score ≤3,
- Hodkinson Mental Test ≥ 6,
- Individuals who agree to having treatment will be included in the study.
Who cannot join
- Having vision and hearing problems,
- Having other neurological, psychiatric and / or orthopedic problems other than hemiparesis,
- Medically unstable,
- Have other diagnosed diseases that will affect lower extremity sensation,
- Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our study is to assess the effect of lower limb sensory training on proprioception, balance, gait and motor functions in Hemiparetic Individuals.
Read the detailed description
After being informed about the study, all patients giving written informed consent will be determined eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a single-blind manner (investigor about assessments). A group will have Bobath Therapy and the other group Bobath and Sensory Training.
- Being tested
- neurodevelopmental therapy, Lower extremity sensory training
- Medical subject headings
- Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodevelopmental therapyOther
Also called Bobath Therapy
Considering the individual needs and wishes of the patient, an exercise program will be created for each patient in accordance with their functional levels and supporting active participation of the person. The treatment program tailored to the patient; It will include weight transfer to the affected side in different positions, functional reaching out activities, stepping forward and walking activities.
Lower extremity sensory trainingOther
Lower extremity sensory training will only be applied to the Intervention Group for 4 weeks, 3 days a week and 12 sessions in total. In the lower extremity, 3 sets of soft tissue needing, stroking and fascia stretching will be applied on 5 areas as Quadriceps, Hamstring, Gastrosoleus Group, Peroneal muscles, ankle and foot. In addition, sensory stimulation will be applied in the same five regions of the lower extremity with 3 repetitions and 3 sets with a knurled ball, brush and sponge. Lower extremity mobilizations of PANat Therapy approach will be used with traction and gliding applications in all joints in the ankle and foot. Finally, intrinsic muscle stimulation will be performed for 3 minutes with a bottle and towel under the sole of the foot.
| Study group | Role | What they receive |
|---|---|---|
| Lower Extremity Sensory Training + Bobath Therapy | Experimental | Intervention Group will have Lower extremity sensory training and Bobath Therapy. Receives: Other: neurodevelopmental therapy; Other: Lower extremity sensory training |
| Bobath Therapy | Active comparator | Control Group will have only Bobath Therapy. Bobath approach will be applied for 4 weeks, 3 days a week and 12 sessions in total. Receives: Other: neurodevelopmental therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Level
Motricity Index (MI) will be used to determine motor function levels. Since the lower extremity functions after hemiparesis are evaluated in the study, the lower extremity score of the Motricity Index will be calculated. In the lower extremity, hip flexion muscle strength, knee extension muscle strength, and ankle dorsi flexion muscle strength will be evaluated in the sitting position. Each muscle is evaluated over 33. The highest score obtained from the test is 100 and shows the best functionality.
Measured: 4 weeks
Foot Sole Sense
he evaluation will be done with Semmes Weinstein Monofilaments (SWM) in the supine position. Monofilaments will be held perpendicular to the surface, and they will be contacted for 1.5-2 seconds by pressing until there is a slight bend in the monofilament. Individuals will be informed to say "yes" when they feel the contact, and the responses obtained from the patient will be recorded. The application will be evaluated in seven regions on the sole of the foot: the big toe, the little toe, the first metatarsal, the fifth metatarsal, the lateral border of the foot, the medial border of the foot, and the medial border of the heel. Thicknesses in the test kit range have from 1.65 to 6.55. The 6.65 is the loss of protective sensation and is the worst result.
Measured: 4 weeks
Lower Extremity Position Test
It was developed for the evaluation of proprioseption after stroke. Two 12 cm and 22 cm lines are drawn in the middle of the A4 paper. The patient is seated on a flat chair and the toes are adjusted to match the tip of the paper. The eyes of the patient are closed, the tips of the toes are brought over the line twice passively, and in the next evaluation, the patient is informed about "stop" and the difference is recorded in cm. The smaller is the difference, the better is proprioseption.
Measured: 4 weeks
Kinesthesia Sense
Measurement will be done with electrogoniometer in the sitting position. 60 degrees hip flexion, 60 degrees knee flexion and 10 degrees ankle plantar flexion angles will be performed on the healthy leg in 5 repetitions, then three measurements will be taken from the hemiparetic leg.
Measured: 4 weeks
Balance Assessment
The device consists of two parts, an electronic inclination sensor and a moving platform. There is a red cross on the computer screen indicating the movement of the platform. The assessed person tries to keep this sign on the screen in the center for 30 seconds. At the end of the test, the device calculates a balance score.
Measured: 4 weeks
Evaluation of Gait Parameters
In the gait analysis system, the results are transferred to the computer via bluetooth with the analysis port attached to the patient's L5-S1 level. After walking, the resulting reports are automatically generated.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Dec 2020
- Primary completion20 Sep 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)Studies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsum Tikac, Pamukkale University
- Investigators
- Gulsum Tikac, MSc Pt, Principal investigator, Pamukkale UniversityFiliz Altuğ, Prof Dr, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673838
- Sponsor's protocol ID
- Hemiparetic Sensory Training
- Status last verified
- Mar 2021
- First submitted
- 11 Dec 2020
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
- ClinicalTrials.gov ID
- NCT04673838
- Acronym / sponsor ID
- Hemiparetic Sensory Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 17 Dec 2020 (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 purpose of our study is to assess the effect of lower limb sensory training on proprioception, balance, gait and motor functions in Hemiparetic Individuals.
Detailed description
After being informed about the study, all patients giving written informed consent will be determined eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a single-blind manner (investigor about assessments). A group will have Bobath Therapy and the other group Bobath and Sensory Training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Extremity Sensory Training + Bobath Therapy | Experimental | Other: neurodevelopmental therapy, Other: Lower extremity sensory trainingIntervention Group will have Lower extremity sensory training and Bobath Therapy. |
| Bobath Therapy | Active comparator | Other: neurodevelopmental therapyControl Group will have only Bobath Therapy. Bobath approach will be applied for 4 weeks, 3 days a week and 12 sessions in total. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 20-65 and discharged from the hospital,
- Having been diagnosed with hemiparesis at least 4 weeks ago,
- First time and one-sided hemiparesis,
- Modified Rankin Score ≤3,
- Hodkinson Mental Test ≥ 6,
Key exclusion criteria (5 listed)
- Having vision and hearing problems,
- Having other neurological, psychiatric and / or orthopedic problems other than hemiparesis,
- Medically unstable,
- Have other diagnosed diseases that will affect lower extremity sensation,
- Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.
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 |
|---|---|---|
| neurodevelopmental therapyAlso: Bobath TherapyConsidering the individual needs and wishes of the patient, an exercise program will be created for each patient in accordance with their functional levels and supporting active participation of the person. The treatment program tailored to the patient; It will include weight transfer to the affected side in different positions, functional reaching out activities, stepping forward and walking activities. | Other | Bobath Therapy, Lower Extremity Sensory Training + Bobath Therapy |
| Lower extremity sensory trainingLower extremity sensory training will only be applied to the Intervention Group for 4 weeks, 3 days a week and 12 sessions in total. In the lower extremity, 3 sets of soft tissue needing, stroking and fascia stretching will be applied on 5 areas as Quadriceps, Hamstring, Gastrosoleus Group, Peroneal muscles, ankle and foot. In addition, sensory stimulation will be applied in the same five regions of the lower extremity with 3 repetitions and 3 sets with a knurled ball, brush and sponge. Lower extremity mobilizations of PANat Therapy approach will be used with traction and gliding applications in all joints in the ankle and foot. Finally, intrinsic muscle stimulation will be performed for 3 minutes with a bottle and towel under the sole of the foot. | Other | Lower Extremity Sensory Training + Bobath Therapy |
Primary outcome
Functional Level
Time frame: 4 weeks
Motricity Index (MI) will be used to determine motor function levels. Since the lower extremity functions after hemiparesis are evaluated in the study, the lower extremity score of the Motricity Index will be calculated. In the lower extremity, hip flexion muscle strength, knee extension muscle strength, and ankle dorsi flexion muscle strength will be evaluated in the sitting position. Each muscle is evaluated over 33. The highest score obtained from the test is 100 and shows the best functionality.
Foot Sole Sense
Time frame: 4 weeks
he evaluation will be done with Semmes Weinstein Monofilaments (SWM) in the supine position. Monofilaments will be held perpendicular to the surface, and they will be contacted for 1.5-2 seconds by pressing until there is a slight bend in the monofilament. Individuals will be informed to say "yes" when they feel the contact, and the responses obtained from the patient will be recorded. The application will be evaluated in seven regions on the sole of the foot: the big toe, the little toe, the first metatarsal, the fifth metatarsal, the lateral border of the foot, the medial border of the foot, and the medial border of the heel. Thicknesses in the test kit range have from 1.65 to 6.55. The 6.65 is the loss of protective sensation and is the worst result.
Lower Extremity Position Test
Time frame: 4 weeks
It was developed for the evaluation of proprioseption after stroke. Two 12 cm and 22 cm lines are drawn in the middle of the A4 paper. The patient is seated on a flat chair and the toes are adjusted to match the tip of the paper. The eyes of the patient are closed, the tips of the toes are brought over the line twice passively, and in the next evaluation, the patient is informed about "stop" and the difference is recorded in cm. The smaller is the difference, the better is proprioseption.
Kinesthesia Sense
Time frame: 4 weeks
Measurement will be done with electrogoniometer in the sitting position. 60 degrees hip flexion, 60 degrees knee flexion and 10 degrees ankle plantar flexion angles will be performed on the healthy leg in 5 repetitions, then three measurements will be taken from the hemiparetic leg.
Balance Assessment
Time frame: 4 weeks
The device consists of two parts, an electronic inclination sensor and a moving platform. There is a red cross on the computer screen indicating the movement of the platform. The assessed person tries to keep this sign on the screen in the center for 30 seconds. At the end of the test, the device calculates a balance score.
Evaluation of Gait Parameters
Time frame: 4 weeks
In the gait analysis system, the results are transferred to the computer via bluetooth with the analysis port attached to the patient's L5-S1 level. After walking, the resulting reports are automatically generated.
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 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Recruiting
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Stroke, Acute, Stroke, Ischemic
Recruiting
Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder
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.
Gulsum Tikac, MSc Pt principal investigator
Pamukkale University
Filiz Altuğ, Prof Dr study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurodevelopmental therapy and Lower extremity sensory training in people with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), run by Pamukkale 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 5 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 3 Jun 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?
Functional Level (time frame: 4 weeks). The study lists 6 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 3 Jun 2025.