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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05191524
Collaborator
(none)
30
1
2
5.4
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Constrained induced movement
  • Other: Proprioceptive Neuromuscular facilitation
N/A

Detailed Description

There have been many rehabilitation techniques to treat post-stroke impairments. These include aerobic exercises, the Bobath approach, proprioceptive neuromuscular facilitation (PNF) constraint-induced movement therapy (CIMT), and mobilization and stimulation of neuromuscular tissue. The selection of techniques at the defined level of recovery varies among clinicians.

Constraint-induced movement therapy (CIMT) is a neurological rehabilitation technique that has been used in various neurological disorders including stroke both in acute and chronic stages, traumatic brain injury, cerebral palsy, multiple sclerosis, and spinal cord injury to improve motor function and strengthen weak muscles which are characterized by the restraint of the less affected extremity accompanied by the shaping and repetitive task-oriented training of more affected extremity.

Proprioceptive facilitation (PNF) is one of the major therapeutic techniques aimed at enhancing the essential characteristics required for the functional ambulation of patients with hemiplegia, such as muscular control, strength, and flexibility. Changes in the excitation of the cortical motor area mediate this and the corresponding.

Motor neurons. Previous researches are on the separate effect of CIMT and they have conducted PNF approaches, but there is no study available on the comparison of the effect of both techniques on lower limb function in stroke patients. Most of the studies administered PNF in combination with other approaches and the duration of intervention in these studies was in favor of CIMT groups compared to PNF. Therefore, this study is aimed at determining the comparative effect of CIMT and PNF on lower limb recovery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function in Stroke Patients
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Jun 27, 2022
Anticipated Study Completion Date :
Jun 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Constrained induced movement therapy

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
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.

Active Comparator: Proprioceptive Neuromuscular facilitation therapy

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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment (FMA) [week 6]

    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).

  2. Timed up and go test [week 6]

    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

  3. Berg Balance Scale [week 6]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helping Hand institute of Rehabilitation Sciences Mansehra Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ayesha Afridi, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05191524
Other Study ID Numbers:
  • REC/00818 Aqdas
First Posted:
Jan 13, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022