Lower Extremity Pressure Splints in HP

NCT06965894 | Recruiting

• 1 other identifier: 02052025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hemiplegia (weakness or paralysis on one side of the body) often impacts the lower extremities, making it challenging for patients to walk or move their legs effectively. This study aims to explore the effects of pressure splints on the lower extremity movement and function in individuals who have experienced a stroke and suffer from hemiplegia. Pressure splints are specialized devices designed to support and enhance muscle function by applying gentle pressure to the affected limbs. Participants in this study will be randomly assigned to one of two groups: the Splint Group (SG) or the Control Group (CG). The duration of the intervention will be six weeks. During this period, all the participants will receive neurodevelopmental therapy. In the SG exercises will be done with the help of the lower extremity pressure splints while participants in the CG will join the exercises without any splint. This study is significant as it may lead to the development of new methods to enhance recovery for stroke patients and offer better rehabilitation options.

Conditions

Hemiplegia; Lower Extremity Dysfunction; Stroke Rehabilitation

Keywords

Stroke; Rehabilitation; Gait; Johnstone Splint; Motor Recovery

Outcome Measures

Primary Outcomes (4)

• Lower Extremity Motor Function

  The improvement in motor function of the lower extremity will be assessed by Fugl-Meyer Assessment for Lower Extremity (FMA). The FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 34.

  Through study completion, an average of 8 months

• Balance

  The Berg Balance Scale (BBS) will be used to assess balance. This scale objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

  Through study completion, an average of 8 months

• Lower Extremity Strength

  The Five Times Sit to Stand Test will be used for the assessment of lower limb strength along with balance and postural control. Score is the amount of time it takes for an patient to transfer from a seated position to standing position and back to sitting five times.

  Through study completion, an average of 8 months

• Mobility

  Mobility will be assessed by Timed Up and Go (TUG). TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

  Through study completion, an average of 8 months

Secondary Outcomes (4)

• Stroke Recovery

  Through study completion, an average of 8 months

• Ambulation

  Through study completion, an average of 8 months

• Independence

  Through study completion, an average of 8 months

• Muscle Tone

  Through study completion, an average of 8 months

Study Arms (2)

Splint Group

EXPERIMENTAL

Participants in this group will receive a rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques. In addition to the rehabilitation program, a Johnston pressure splint will be applied to the affected lower extremity during therapy sessions. The intervention aims to provide controlled pressure and support to improve motor recovery, balance, and gait in hemiplegic stroke patients.

Device: Johnston Pressure Splint; Other: Rehabilitation Program

Control Group

ACTIVE COMPARATOR

Participants in this group will receive a rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques without the pressure splint. This group will serve to compare the effects of standard rehabilitation alone versus rehabilitation combined with pressure splinting.

Other: Rehabilitation Program

Interventions

Johnston Pressure Splint DEVICE

Application of a Johnston pressure splint to the lower extremity.

Splint Group

Rehabilitation Program OTHER

Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.

Control Group; Splint Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having hemiplegia because of stroke
• Time since stroke: 1 month to 1 year
• Ability to Participate (a score of \>24 on the Mini-Mental State Examination).
• Being voluntary
• Age between 50-80

You may not qualify if:

• Severe Cognitive Impairment Other Neurological Disorders Severe Comorbidities or Spasticity on Lower Extremity Contraindications to Exercise Recurrent Stroke

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Monseigneur Cortbawi Hospital

Jounieh, Keserwan, 1200, Lebanon

RECRUITING

MeSH Terms

Conditions

Hemiplegia; Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mansour Dib, Doctor

  Mgr Cortbawi Hospital

  STUDY CHAIR

Central Study Contacts

Çiçek Günday, Asst. Prof.

CONTACT

0090 850 283 60 00; cicek.gunday@istinye.edu.tr

Ousama Maarbani, Physiotherapist

CONTACT

0090 850 283 60 00; ousama.maarbani@stu.istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 11, 2025
• Study Start: May 13, 2025
• Primary Completion: January 13, 2026
• Study Completion: February 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)