Back to resultsThe Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
Primary Purpose
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
neurodevelopmental therapy
Lower extremity sensory training
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Eligibility Criteria
Inclusion Criteria: for Intervention and Control Group:
- 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.
Exclusion Criteria:for Intervention and Control Group:
- 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.
Sites / Locations
- Pamukkale UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lower Extremity Sensory Training + Bobath Therapy
Bobath Therapy
Arm Description
Intervention Group will have Lower extremity sensory training and Bobath Therapy.
Control Group will have only Bobath Therapy. Bobath approach will be applied for 4 weeks, 3 days a week and 12 sessions in total.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04673838
Brief Title
The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
Official Title
The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lower Extremity Sensory Training + Bobath Therapy
Arm Type
Experimental
Arm Description
Intervention Group will have Lower extremity sensory training and Bobath Therapy.
Arm Title
Bobath Therapy
Arm Type
Active Comparator
Arm Description
Control Group will have only Bobath Therapy. Bobath approach will be applied for 4 weeks, 3 days a week and 12 sessions in total.
Intervention Type
Other
Intervention Name(s)
neurodevelopmental therapy
Other Intervention Name(s)
Bobath Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lower extremity sensory training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Level
Description
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.
Time Frame
4 weeks
Title
Foot Sole Sense
Description
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.
Time Frame
4 weeks
Title
Lower Extremity Position Test
Description
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.
Time Frame
4 weeks
Title
Kinesthesia Sense
Description
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.
Time Frame
4 weeks
Title
Balance Assessment
Description
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.
Time Frame
4 weeks
Title
Evaluation of Gait Parameters
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: for Intervention and Control Group:
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.
Exclusion Criteria:for Intervention and Control Group:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gulsum Tikac, MSc Pt
Phone
+905393098904
Email
gtikac@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulsum Tikac, MSc Pt
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filiz Altuğ, Prof Dr
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulsum Tikac, MSc Pt
Phone
05393098904
Email
gtikac@pau.edu.tr
First Name & Middle Initial & Last Name & Degree
Gulsum Tikac, MSc Pt
First Name & Middle Initial & Last Name & Degree
Filiz Altuğ, Prof Dr
First Name & Middle Initial & Last Name & Degree
Ayşe Ünal, Phd Pt
First Name & Middle Initial & Last Name & Degree
Emre Baskan, Assist Prof
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
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