Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients

Not Applicable

Completed

• Conditions: Cervical Spinal Cord Injury
• Interventions: Other: Conventional physical therapy; Other: Blood flow restriction

• Registration Number: NCT05425238
• Lead Sponsor: Riphah International University

Brief Summary

This study is conducted to investigate the effects of low load Blood Flow Resistance exercise to improve strength and transfer in lower cervical spinal cord injury patientsCervical Spinal Cord injury patients have very less window of opportunity towards functional mode of life. In complete cervical spinal cord injuries only few muscles of upper limb are completely innervated and it is a need to gain maximum output and advantage out of that. Through conventional strength training it is possible to make him do unsupported sitting and transfer But with BFR-RE it may have a possibility to do this procedure in less time than the conventional strength training and patient will save cost of hospital stay as he may timely discharge from hospital early

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-15
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Primary Completion: 2022-11-15
• Study Completion: 2022-12-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Both male and female, with age between 16-50 years.
• Patients evaluated with C6 to C8 tetraplegic complete injury.
• Patients classified in ASIA A, ASIA B.
• At least Muscle grading of grade 2.
• Patients with sub-acute, chronic stage.

Exclusion Criteria

• Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases.
• Patients with muscles strength grading of less than 2.
• Undergone nerve transfer surgery.
• Patients with acute stage.
• History of DVT.
• Patients who are already performing structured physical activities such as muscle Strengthening exercises.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physical therapy	Conventional physical therapy	Resistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks
Blood flow restriction	Blood flow restriction	Resistance training protocol but with Blood flow restriction technique Standard BFR Application: a standard pressure (used for all patients) for e.g. 180 mmHg; a pressure relative to the patient's systolic blood pressure, for e.g. 1.2 - or 1.5-fold greater than systolic blood pressure.

Primary Outcome Measures

Name	Time	Method
VAS- Visual Analogue Scale	6th week	To measure the intensity of pain
MAS- Modified Ashworth Scale	6th week	To measure the muscular hypertrophy and increased tone. Usually used to measure increased tone in spasticity but also used to measure hypertrophy resulted from normal muscles adaptations.
QIF-SF -- Quadriplegia Index Of Functionality-Small Form	6th week	To the transfer and functional ability in tetraplegic patients.
Hand Held Dynamometer	6th week	To measure the strength objectively and To measure the minor but notable changes in strength change which cannot be detected by MMT

Trial Locations

Locations (1)

Lahore general Hospital; 🇵🇰 Lahore, Punjab, Pakistan