Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function

NCT05191524 | Completed DMC

• 1 other identifier: REC/00818 Aqdas
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke, described as a neurological deficit caused by the interruption of cerebral blood flow, is one of the leading causes of mortality and morbidity throughout the world. It is the second most common medical condition and the major cause of disability in adults. Recovery following stroke revolves around the severity of sensory, motor, and cognitive impairments. Lower extremity impairment is one of the major post-stroke conditions which can cause difficulty in performing activities of daily living, gait abnormalities, increased risk of fall, and restriction in social participation. Rehabilitation after stroke is the primary mechanism through which it can achieve functional recovery and independence, which is based on the principles of motor learning and neuroplasticity.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment (FMA)

  The FMA scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. They divided it into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).

  week 6

• Timed up and go test

  The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers \< 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone \> 30s Requires assistance dependent in most activities

  week 6

• Berg Balance Scale

  The Berg balance scale is used to 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 comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

  week 6

Study Arms (2)

Constrained induced movement therapy

EXPERIMENTAL

In this group of patients, they will use the CIMT technique for treatment. Patient will perform following tasks, while unaffected limb in constrains for 3 hours/day * Sit-to-Stand * Forward and Backward stepping * Stair Climbing and Descending (only the first stair will be used) * Side-to-Side stepping with the affected limb

Other: Constrained induced movement

Proprioceptive Neuromuscular facilitation therapy

ACTIVE COMPARATOR

Different PNF components (such as commands, stretching, timing, and manual resistance) will be used for optimizing patients' output. We will do ten repetitions of each pattern before Proceeding to the next pattern. The PNF patterns in the set used in the study will be : Lower extremity: \< Flexion-abduction-external rotation (knee flexed and knee extended) \< Extension-adduction-internal rotation (knee flexed and knee extended) \< Flexion-adduction-internal rotation (knee flexed and knee extended) \< Extension-abduction-external rotation (knee flexed and knee extended

Other: Proprioceptive Neuromuscular facilitation

Interventions

Constrained induced movement OTHER

Practice in two sessions per day (supervised) for 3 days per week, for six consecutive weeks. The unaffected limb will be constraint using a knee immobilizer only during practice sessions. We will perform the interventions under the supervision of a trained physiotherapist.

Constrained induced movement therapy

Proprioceptive Neuromuscular facilitation OTHER

Group B will receive PNF intervention given for 30 minutes to the lower limb 3 times a week for 6 weeks

Proprioceptive Neuromuscular facilitation therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female
• Patients who will be diagnosed with hemiplegia due to stroke
• Patient who has an asymmetrical stance, ability to walk and stand with minimal assistance
• Patient must have 15 degrees of knee flexion in the affected limb
• Mini mental state examination Mini Mental State Examination \>23

You may not qualify if:

• Patients who cannot perform the active movement of a limb due to pre stroke musculoskeletal problems
• Cardiopulmonary diseases which could hinder their ability to take part in rehabilitation
• Patient with impaired cognition

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Helping Hand institute of Rehabilitation Sciences

Mansehra, Pakistan

Location

Related Publications (9)

• Çoban O. İnmeli hastalarda mekanik hippoterapi cihazı ile yapılan egzersizin postural kontrol ve denge üzerine etkisi. 2019

  BACKGROUND

• Abba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraint-induced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5

  BACKGROUND

• He L, Wang J, Wang F, Zhang L, Zhang L, Zhao W. Increased neutrophil-to-lymphocyte ratio predicts the development of post-stroke infections in patients with acute ischemic stroke. BMC Neurol. 2020 Sep 1;20(1):328. doi: 10.1186/s12883-020-01914-x.

  PMID: 32873248 BACKGROUND

• Randolph SA. Ischemic Stroke. Workplace Health Saf. 2016 Sep;64(9):444. doi: 10.1177/2165079916665400.

  PMID: 27621261 BACKGROUND

• Yu L, Tao J, Zhao Q, Xu C, Zhang Q. Confirmation of potential neuroprotective effects of natural bioactive compounds from traditional medicinal herbs in cerebral ischemia treatment. J Integr Neurosci. 2020 Jun 30;19(2):373-384. doi: 10.31083/j.jin.2020.02.63.

  PMID: 32706202 BACKGROUND

• Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97.

  PMID: 19919699 BACKGROUND

• Ojaghihaghighi S, Vahdati SS, Mikaeilpour A, Ramouz A. Comparison of neurological clinical manifestation in patients with hemorrhagic and ischemic stroke. World J Emerg Med. 2017;8(1):34-38. doi: 10.5847/wjem.j.1920-8642.2017.01.006.

  PMID: 28123618 BACKGROUND

• Chen S, Zeng L, Hu Z. Progressing haemorrhagic stroke: categories, causes, mechanisms and managements. J Neurol. 2014 Nov;261(11):2061-78. doi: 10.1007/s00415-014-7291-1. Epub 2014 Mar 5.

  PMID: 24595959 BACKGROUND

• GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.

  PMID: 28931491 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: January 15, 2022
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)