| 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 |
|
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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 |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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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. |
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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
|
|
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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
|
|
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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. |