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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Activity base therapy
Strength training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Binash afzal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Activity base therapy

Strength training

Arm Description

Outcomes

Primary Outcome Measures

SCIM spinal cord independance measure
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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2021
Last Updated
March 26, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04823078
Brief Title
Effects of Activity Based Therapy on Upper Limb Strength and Transfer in Spinal Cord Injury Patients
Official Title
Effects of Activity Based Therapy on Upper Limb Strength and Transfer in Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activity base therapy
Arm Type
Active Comparator
Arm Title
Strength training
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Activity base therapy
Intervention Description
activity based therapy Weight bearing activities of daily living like vertical lifting, bilateral body weight shifting, lifting and shifting, forward reaching and sideways reaching.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
Strengthening exercises of upper limb involved muscles (elbow extensors, shoulder adductors, abductors, wrist extensors, shoulder protractors and retractors
Primary Outcome Measure Information:
Title
SCIM spinal cord independance measure
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Binash afzal
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25621206
Citation
Nas K, Yazmalar L, Sah V, Aydin A, Ones K. Rehabilitation of spinal cord injuries. World J Orthop. 2015 Jan 18;6(1):8-16. doi: 10.5312/wjo.v6.i1.8. eCollection 2015 Jan 18.
Results Reference
background
PubMed Identifier
31127198
Citation
Divanoglou A, Trok K, Jorgensen S, Hultling C, Sekakela K, Tasiemski T. Active Rehabilitation for persons with spinal cord injury in Botswana - effects of a community peer-based programme. Spinal Cord. 2019 Oct;57(10):897-905. doi: 10.1038/s41393-019-0300-6. Epub 2019 May 24.
Results Reference
background
PubMed Identifier
27630612
Citation
Brogioli M, Schneider S, Popp WL, Albisser U, Brust AK, Velstra IM, Gassert R, Curt A, Starkey ML. Monitoring Upper Limb Recovery after Cervical Spinal Cord Injury: Insights beyond Assessment Scores. Front Neurol. 2016 Aug 31;7:142. doi: 10.3389/fneur.2016.00142. eCollection 2016.
Results Reference
background
PubMed Identifier
28571527
Citation
Hachem LD, Ahuja CS, Fehlings MG. Assessment and management of acute spinal cord injury: From point of injury to rehabilitation. J Spinal Cord Med. 2017 Nov;40(6):665-675. doi: 10.1080/10790268.2017.1329076. Epub 2017 Jun 1.
Results Reference
background
PubMed Identifier
28628595
Citation
Behrman AL, Ardolino EM, Harkema SJ. Activity-Based Therapy: From Basic Science to Clinical Application for Recovery After Spinal Cord Injury. J Neurol Phys Ther. 2017 Jul;41 Suppl 3(Suppl 3 IV STEP Spec Iss):S39-S45. doi: 10.1097/NPT.0000000000000184.
Results Reference
background
PubMed Identifier
27809702
Citation
Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20.
Results Reference
background
PubMed Identifier
32157078
Citation
Argetsinger LC, Singh G, Bickel SG, Calvery ML, Behrman AL. Spinal cord injury in infancy: activity-based therapy impact on health, function, and quality of life in chronic injury. Spinal Cord Ser Cases. 2020 Mar 10;6(1):13. doi: 10.1038/s41394-020-0261-1.
Results Reference
background
PubMed Identifier
31068745
Citation
Behrman AL, Argetsinger LC, Roberts MT, Stout D, Thompson J, Ugiliweneza B, Trimble SA. Activity-Based Therapy Targeting Neuromuscular Capacity After Pediatric-Onset Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2019 Spring;25(2):132-149. doi: 10.1310/sci2502-132.
Results Reference
background
PubMed Identifier
31019375
Citation
de Oliveira CQ, Middleton JW, Refshauge K, Davis GM. Activity-Based Therapy in a Community Setting for Independence, Mobility, and Sitting Balance for People With Spinal Cord Injuries. J Cent Nerv Syst Dis. 2019 Apr 12;11:1179573519841623. doi: 10.1177/1179573519841623. eCollection 2019.
Results Reference
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Effects of Activity Based Therapy on Upper Limb Strength and Transfer in Spinal Cord Injury Patients

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