Effects of Activity Based Therapy on Upper Limb Strength and Transfer in Spinal Cord Injury Patients

March 26, 2021 updated by: Riphah International University

In our society spinal cord injury is a major problem.activity based therapy and conventional therapy has a potentional to improve upper limb strength and transfer in tetraplegic patients.

The aim of this study is to determine the effects of activity based therapy versus conventional therapy to improve the upper limb strength and transfer in spinal cord injury.

The study design used was randomized clinical trial. The study was conducted at the paraplegic center Peshawar in 6 weeks after the approval of synopsis. A sample size of 16 participants was taken with complete and incomplete spinal cord injury received using lottery method. Subjects were randomly divided into 2 groups. Group A was treated with activity based therapy + baseline therapy and group B was treated with conventional therapy + baseline therapy. 8 subjects in each group. Pre and post treatment evaluation were done by using Spinal cord independence measure scale (SCIM) and International standards for neurological classification of spinal cord injury upper extremity measurement scale (ISNCSCI- UEMS).

Post spinal cord independence measure activity based group mean 26.87±12.87 and conventional group mean 31.50±23.82. The results indicate that conventional therapy and activity based therapy both are helpful in improving upper limb strength and transfer total spinal cord independence measure pre sig.0.96 and post sig.0.57.

Both activity based therapy and conventional therapy equally effective for improving the upper limb strength and transfer in spinal cord injury.

entional therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spinal cord is the cylindrical structure of nerve fibers and tissues that is enclosed in the spine and provides connection between the brain and all parts of the body. The spinal cord is particularly prone to injury. The spinal cord does not have the ability to repair other parts of the body, if it is damaged. A spinal cord injury happens when the spinal cord is affected by trauma, loss of its normal blood flow, or tumor or infection compression. Lesions in the spinal cord are described as either complete or incomplete.In a complete spinal cord injury, the body suffers complete loss of sensation and muscle control below the injury stage. In an incomplete injury to the spinal cord, there is a certain stay behind feature below injury point. In most cases all sides of the body are similarly affected. Neck injuries to the upper portion of the spinal cord can cause quadriplegia-paralysis of both arms and legs. If the spinal cord injury occurs lower in the back then it can only induce paraplegia-paralysis of both legs. The incidence of SCI to be between 13 and 33 cases per million per year, and their estimate of the incidence of SCI was between 110 and 1120 per million populations. Quadriplegia term refers to the motor and sensory function of cervical spinal cord because neurons inside the neuron damaged the spinal canal. Quadriplegia can cause in the arms, trunk, legs and pelvic organs. Not including brachial plexus or peripheral nervous injury.Trauma is the principal cause of spinal cord injury. Nearly half of the incidents are attributed to accidents involving motor vehicles. Certain forms of trauma include: falling to the spine from a height, stabbing or gunshot wound and sports injuries. Spinal cord damage may also be caused by tumor, infection, or inflammation caused by compression of the spinal cord. Many patients have normal backbone canal and a higher risk of spinal cord injurySome prognostic factors are related to survival, includes demographic, injury, and psychosocial variables. The most important prognostic factors are age and severity of injury including the level of the nervous system, the degree of damage integrity, and ventilator dependence Patients with spinal cord injury (SCI), especially those with higher levels of disease, rely on care and assistance in their daily activities, most of which are provided by informal caregivers. Where home caregivers are involved, low usage of home services is observed. Provides care based on a doctor's prescription based on care needs, assessed by a qualified service provider using standardized procedures.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Binash afzal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants with C6 to T1 tetraplegia.
  • Both male and female patients were included
  • Participants with traumatic spinal cord injury
  • Participants with well oriented behavior were included
  • Participants with complete and in complete spinal cord injury
  • Participants of all times post injury and any initial sitting were included

Exclusion Criteria:

  • Any intervention that measure effectiveness of external devices such as orthotics, frames sittings and chair positions
  • Participants with severe neurological disorders, psychological problems and cognitive issues.
  • Paraplegic participants or participants involved in gait or walking balance training over ground
  • Participants with severe co morbidities and other medical complications
  • Participants with pressure ulcers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Activity base therapy
Other: Activity base therapy

activity based therapy

Weight bearing activities of daily living like vertical lifting, bilateral body weight shifting, lifting and shifting, forward reaching and sideways reaching.
OTHER: Strength training
Other: Strength training
Strengthening exercises of upper limb involved muscles (elbow extensors, shoulder adductors, abductors, wrist extensors, shoulder protractors and retractors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCIM spinal cord independance measure
Time Frame: 6th week
The Spinal Cord Independence Measure version II (SCIM) was used to assess the ability to accomplish activities of daily living. This scale assesses three areas: (1) self-care (feeding, grooming, bathing, and dressing); (2) respiration and sphincter management; and (3) mobility (bed, transfers, and indoor/outdoor).18 The SCIM III has demonstrated high internal consistency (Cronbach's α = 0.77-0.91) and inter-rater reliability (ICC = 0.96). Moreover, it has shown responsiveness similar to the Functional Independence Measure (FIM).19-21 Ceiling effects were observed in three items: Feeding, Respiration, and Bed mobility, whereas floor effects were observed in 11 items: feeding, bathing (upper and lower body), dressing (upper and lower body), use of toilet, bed mobility, transfers from wheelchair (to bed, toilet, car, and ground), and stair management. changes from the baseline assessed.
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2019

Primary Completion (ACTUAL)

February 20, 2020

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (ACTUAL)

March 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/19/1009 Namra Urooj

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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