A clinical trial to study the effectiveness of modified ground reaction ankle foot orthosis in subjects with spastic diplegic cerebral palsy on balance

Effectiveness of Modified Ground Reaction Ankle Foot Orthosis (GRAFO) in Subjects with Spastic Diplegic Cerebral Palsy on Static and Dynamic Balance - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057844

Enrollment

Registered

2023-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G801- Spastic diplegic cerebral palsy

Interventions

Intervention1: Modified Ground Reaction Ankle Foot Orthosis(MGRAFO): In this study Modified GRAFO is one piece construction (3mm polypropylene sheet) • Used for spastic diplegic patients. • Mediolater

Eligibility

Inclusion criteria

Inclusion criteria: • Spastic cerebral palsy with a Modified Ashworth Scale (MAS) Grade 1 and 1+ of dorsiflexion group of muscles. • Cerebral palsy with crouch gait • Subject should be independently ambulatory. • Able to understand the command given. .

Exclusion criteria

Exclusion criteria: • Children having convulsions • Fixed deformities in the lower limbs • Any fixed flexion contractures in the hip and knee • Subject with other musculoskeletal pathology (scoliosis, Duchene Muscular Deformity etc.) • Subject with any other surgical intervention in lower limb extremity in last 6 months • CP with Mental Retardation and multiple disorders.

Design outcomes

Primary

Measure	Time frame
static & dynamic balance-Mini-Balance Evaluation System Test(BESTest)Timepoint: AT baseline & after 3 months of intervention	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactSantosh Jha

Pandit Deendayal Upadhyaya National Institute for Person with Physical Disabilities

smitank7@gmail.com7703878714

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026