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CTRI Number  CTRI/2021/03/032439 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 10/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Short term effects of functional music combined with body weight supported treadmill training on walking pattern and balance in individuals with incomplete spinal cord injury. 
Scientific Title of Study   Short term effects of Rhythmic Auditory Stimulation with Body Weight Supported Treadmill Training on gait and balance in individuals with incomplete spinal cord injury. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chitra Kataria 
Designation  Chief of Rehabilitation Services, and Principal, ISIC Institute of Rehabilitation Sciences 
Affiliation  Indian Spinal Injuries Centre Hospital 
Address  Rehabilitation Department, Indian Spinal Injuries Centre Hospital, Sector -C New Delhi

South
DELHI
110070
India 
Phone  011-42255222  
Fax    
Email  chitrakataria@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitra Kataria 
Designation  Chief of Rehabilitation Services, and Principal, ISIC Institute of Rehabilitation Sciences 
Affiliation  Indian Spinal Injuries Centre Hospital 
Address  Rehabilitation Department, Indian Spinal Injuries Centre Hospital, Sector -C New Delhi

South
DELHI
110070
India 
Phone  011-42255222  
Fax    
Email  chitrakataria@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Kanika Singhal 
Designation  Student 
Affiliation  Indian Spinal Injuries Centre Hospital 
Address  Rehabilitation Department, ISIC Institute of Rehabilitation and Sciences

South
DELHI
110070
India 
Phone  09650017168  
Fax    
Email  kanikkasinghal8@gmail.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chitra Kataria  ISIC Institute of Rehabilitation Sciences  Rehabilitation Department
South
DELHI 
011-42255222

chitrakataria@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Body weight supported treadmill training   BWSTT is a common gait rehabilitation technique in which individual walk on a treadmill with some of their body weight supported by harness. Total duration of training will be of 2 weeks with a frequency of 5 times per week with each session of 30 minutes. 
Intervention  Rhythmic Auditory Stimulation with Body weight supported treadmill training.  Rhythmic-auditory stimulation (RAS) is defined as a therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or gait related aspects of movement. Body weight supported treadmill training is a common gait rehabilition technique. The total duration of intervention will be of 2 weeks with a frequency of 5 times per week with each session of 30 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Motor incomplete traumatic and non-traumatic, non-progressive spinal cord injury classified as AIS-C and D.
Having achieved assisted standing a minimum of 1 week previously.
 
 
ExclusionCriteria 
Details  Orthopedic injuries that are unstable
Osteoporosis with high risk of pathological fracture
Cutaneous lesions and/or pressure ulcers in areas where the harness or thigh straps are fitted
Joint rigidity
Asymmetry of lower-extremity length more than 2 cm
Pulmonary or heart disease requiring monitoring during exercise
Body weight exceeding 150 kg
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cadence
Step Length
Velocity
Berg Balance Scale
 
At baseline(0 day) and 2 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Walking Index for Spinal Cord Injury II
Instrumental Evaluation of Balance for Postural Sway
Activities Specific Balance Confidence Scale
 
At baseline (0 day) and 2 weeks
 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="8" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2021 
Date of Study Completion (India) 03/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM: Aim of the study is to determine the short term effects of rhythmic auditory stimulation with body weight supported treadmill training on gait and balance in individuals with SCI.

Spinal Cord Injury (SCI) is a sudden onset disruption to the neuronal tissue within the spinal canal resulting in spinal cord damage, which occurs as a result of trauma, disease or degeneration. Spinal Cord Injury can occur as a result of a)non-traumatic causes (16%) secondary to disease, infection and congenital defect or b)trauma (84%), with the most the common occurring as a result of motor vehicle and motor-bike accidents, followed by falls. Sport, in particular, water-based activities and work-related injuries are also common, while violence-related injuries from a gun, stab or war-related injuries are high in some countries.

Patients following spinal cord injury (SCI) may completely or partially lose their ability to walk.  The incidence of falls in people with SCI has been reported to be as high as 75% with loss of balance being the primary perceived factor contributing to falls in incomplete SCI.  

Need of the study - The recovery or improvement of ambulation after a Spinal Cord Injury (SCI) is an important goal because people who can walk independently are more likely to be able to participate in expected social roles and desired recreational activities, have a higher quality of life, and have improved health status. The partial body weight supported treadmill training is a common therapeutic strategy in rehabilitation of people with spinal cord injuries improving their gait and balance. Partial body weight support is provided by an overhead harness while leg  movements are assisted by therapists and a moving treadmill belt.  For gait rehabilitation, rhythmic auditory stimulation is also known to be effective at enhancing the walking ability of neurological patients. Stimulation to the motor centre of the brain demonstrate priming and timing of motor responses via audio-spinal path using sound cues and musical rhythms and activation of central pattern generators enhancing their gait pattern and their balance. This study incorporates use of both the techniques together for enhancing gait and balance of the patient.

 

This study is designed to determine the effectiveness of rhythmic auditory stimulation combined with body weight supported treadmill training on gait and balance in individuals with incomplete SCI.

Effectiveness of intervention will be compared between two groups 1) BWSTT with rhythmic auditory stimulation and 2) BWSTT without rhythmic auditory stimulation.

The outcome measures will focus on gait and balance parameters including velocity, cadence, step length, WISCI II, BBS, ABC SCALE, IEB.

The total duration of intervention will be of 2 weeks with a frequency of 5 times per week with each session of 30 minutes.

Paired and unpaired t- test will be used to evaluate the results.

 
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