The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals

NCT ID: NCT04673838

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lower Extremity Sensory Training + Bobath Therapy

Intervention Group will have Lower extremity sensory training and Bobath Therapy.

Group Type EXPERIMENTAL

neurodevelopmental therapy

Intervention Type OTHER

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 training

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

neurodevelopmental therapy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

neurodevelopmental 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.

Intervention Type OTHER

Lower extremity sensory training

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bobath Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gulsum Tikac

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gulsum Tikac, MSc Pt

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Filiz Altuğ, Prof Dr

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hemiparetic Sensory Training

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasonograpy in Hemiplegic Patients
NCT06706063 ACTIVE_NOT_RECRUITING