NCT07842003

Brief Summary

This pilot interventional study evaluated whether adding wheelchair-adapted Modified Yoga Therapy to conventional physical rehabilitation could improve pulmonary function, respiratory muscle strength, and quality of life in adults with traumatic thoracic spinal cord injury. Participants with operated traumatic thoracic spinal cord injury were assigned to either an experimental group or a control group. The control group received Conventional Physical Rehabilitation Therapy (CPRT), while the experimental group received CPRT together with a 20-minute Modified Yoga Therapy program, five days per week for four weeks. The yoga program included wheelchair-adapted postures, breathing exercises (Pranayama), and relaxation. Outcomes were assessed at baseline and after four weeks and included Peak Expiratory Flow Rate (PEFR), Maximum Inspiratory Pressure (MIP), and quality of life measured using the WHOQOL-BREF questionnaire. The study evaluated whether Modified Yoga Therapy could serve as an adjunct to conventional rehabilitation for individuals with thoracic spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Thoracic Spinal Cord InjuryModified YogaWheelchair-Adapted YogaPulmonary RehabilitationRespiratory Muscle StrengthQuality of LifePranayama

Outcome Measures

Primary Outcomes (2)

  • Peak Expiratory Flow Rate (PEFR)

    Peak Expiratory Flow Rate (PEFR) was assessed using a Helios 401 computerized spirometer to evaluate expiratory pulmonary function. PEFR was recorded in liters per second (L/m).

    Baseline and 4 weeks

  • Maximum Inspiratory Pressure (MIP)

    Maximum Inspiratory Pressure (MIP) was measured using a MicroRPM respiratory pressure meter to assess inspiratory respiratory muscle strength. MIP was recorded in cmH2O.

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Quality of Life (WHOQOL-BREF)

    Baseline and 4 weeks

Study Arms (2)

Modified Yoga Plus Conventional Rehabilitation

EXPERIMENTAL

Participants received Conventional Physical Rehabilitation Therapy (CPRT) combined with Modified Yoga Therapy (MYT). Modified Yoga Therapy was administered for 20 minutes per session, 5 days per week for 4 weeks and included Sukshmakriya, wheelchair-adapted Yogasana, Anulom Vilom Pranayama, and Savasana relaxation.

Behavioral: Conventional Physical Rehabilitation TherapyBehavioral: Modified Yoga Therapy

Conventional Physical Rehabilitation Therapy

ACTIVE COMPARATOR

Participants received Conventional Physical Rehabilitation Therapy (CPRT), including diaphragmatic and pursed-lip breathing exercises, upper-limb strengthening, passive and active lower-limb movements, pelvic bridging, abdominal curl-ups, balance training, mat activities, and standard occupational therapy.

Behavioral: Conventional Physical Rehabilitation Therapy

Interventions

Conventional Physical Rehabilitation Therapy included diaphragmatic breathing, pursed-lip breathing, upper-limb strengthening, passive and active lower-limb movements, pelvic bridging, abdominal curl-ups, balance training, mat activities, and standard occupational therapy.

Conventional Physical Rehabilitation TherapyModified Yoga Plus Conventional Rehabilitation

Modified Yoga Therapy was administered for 20 minutes per session, 5 days per week for 4 weeks. The program included Sukshmakriya, wheelchair-adapted Hastauttanasana, Padahastasana, Ardhmatsyendrasana, Garudasana, Ardhachandrasana, Anulom Vilom Pranayama, and Savasana relaxation.

Modified Yoga Plus Conventional Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with operated traumatic thoracic spinal cord injury at levels T1-T12.
  • Participants who had completed Tilt Table Mobilization with weight-bearing permission from the orthopedic surgeon.
  • Participants classified as American Spinal Injury Association (ASIA) Impairment Scale Grade A or Grade B.

You may not qualify if:

  • Participants with associated chest, rib, or abdominal trauma. Participants who had undergone recent secondary surgeries. Participants with cardiopulmonary diseases. Participants with autonomic dysreflexia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government (CL&SC) Spine Institute and Hospital

Ahmedabad, Gujarat, 380016, India

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of two parallel treatment groups. The experimental group received Conventional Physical Rehabilitation Therapy (CPRT) combined with Modified Yoga Therapy (MYT), while the control group received CPRT alone. Both groups underwent the intervention for four weeks.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

October 1, 2015

Primary Completion

October 25, 2016

Study Completion

November 30, 2016

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

This study has been completed. Individual participant data will not be shared because a formal IPD-sharing plan was not established for this study.

Locations