NCT04823078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 26, 2021

Last Update Submit

March 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6th week

Study Arms (2)

Activity base therapy

ACTIVE COMPARATOR
Other: Activity base therapy

Strength training

OTHER
Other: Strength training

Interventions

activity based therapy Weight bearing activities of daily living like vertical lifting, bilateral body weight shifting, lifting and shifting, forward reaching and sideways reaching.

Activity base therapy

Strengthening exercises of upper limb involved muscles (elbow extensors, shoulder adductors, abductors, wrist extensors, shoulder protractors and retractors

Strength training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, 54000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 25621206BACKGROUND
  • 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.

    PMID: 31127198BACKGROUND
  • 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.

    PMID: 27630612BACKGROUND
  • 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.

    PMID: 28571527BACKGROUND
  • 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.

    PMID: 28628595BACKGROUND
  • 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.

    PMID: 27809702BACKGROUND
  • 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.

    PMID: 32157078BACKGROUND
  • 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.

    PMID: 31068745BACKGROUND
  • 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.

    PMID: 31019375BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Binash Afzal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

June 15, 2019

Primary Completion

February 20, 2020

Study Completion

March 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations