Clincosm LogoSign in Get a demo

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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05425238
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Blood flow restriction
  • Other: Conventional physical therapy
 N/A

Detailed Description

Spinal cord injury is the major concern which can lead to severe impairments and lead to disability. Cervical spinal cord complete injuries patients have a very narrow window of opportunity and we have to gain maximum output and advantage out of that. C6 tetraplegic patients have muscles innervations limited to some groups of upper limb. Even triceps are not innervated in c6 tetraplegic complete injury. However we use special techniques and strengthening of innervated muscles to make him able doing unsupported sitting and transfer from bed to wheel chair. Normally to attain strengthening in a muscle group is achieved by up to 80% of 1 RM. But the spinal cord population cannot endure such heavy loads and has high risk of DVT. So on the safe side clinicians and researches use 30% to 60% 1 RM.

In our study there are two equally distributed groups of complete tetraplegic patients. One will attain strengthening with low load resistance training which conventional training program And Other will attain strengthening with Blood Flow Restriction Resistance Exercise technique with Low Loads in Short, the aim of this study is to test the use of Blood flow restriction - Resistance exercise with low loads as a surrogate for high loads conventional training for strength. BFR Pressure for tourniquet will be 1.2 to 1.5 folds greater than the SBP depending on the AOP. Exercise Guidelines for both group will be 75 repetitions in 4 sets at 4 days a week for 6 weeks. Data will be collected at 0 week and after 6 weeks also. As well as after 15 days date will be collected to see minor but notable changes in strength and hypertrophy. The tools we will use are: VAS- Visual Analogue Scale, MAS- Modified Ashworth Scale, QIF-SF -- Quadriplegia Index Of Functionality- Small Form, Hand Held Dynamometer, Manual muscle testing. The data will be analyzed using SPSS software version 25.0

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Blood Flow Restriction Resistance Exercise on Strength and Transfer in Lower Cervical Spinal Cord Injury Patients
Actual Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Blood flow restriction
strengthening 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.40% cuff pressure as percentage of LOP.(4) And performing BFR-RE with low load exercises. So 30% of 1 RPM would be enough 4 times a week for 6 week
Active Comparator: Conventional physical therapy

Resistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks

Other: Conventional physical therapy
Resistance exercise 75 repetitions across four sets of exercises, with30 repetitions in the first set and 15 repetitions in each subsequent set. 4 times a week for 6

Outcome Measures

Primary Outcome Measures

  1. VAS- Visual Analogue Scale [6th week]

    To measure the intensity of pain and has a good reliability (r= 0.94, P= 0.001) Construct Validity with NPRS= 0.62-0.91

  2. 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. Intra - rater reliability (73.3%) (Kenhalltau-b .567

  3. QIF-SF -- Quadriplegia Index Of Functionality-Small Form [6th week]

    To the transfer and functional ability in tetraplegic patients. Pearson's correlation coefficient ranged from 0.62 to 0.95 (P < 0.001) for individual tasks and most valid for lower cervical spinal cord injuries

  4. Hand Held Dynamometer [6th week]

    To measure the strength objectively Reliability (r = 0.986).To measure the minor but notable changes in strength change which cannot be detected by MMT .(

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lahore general Hospital Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Binash Afzal, PHD*, Riphah international university lahore campus

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05425238
Other Study ID Numbers:
  • REC/RCR&AHS/22/0222
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 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:
Spinal Cord Injuries
Wounds and Injuries

Study Results

No Results Posted as of Jun 21, 2022