Clinical trial NCT06631664: Electrical Stimulation on Erbs Palsy Infants
Official title: Contribution of Reciprocal Electrical Stimulation Across Elbow Muscles in Motor Recovery of Infants With Erbs Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erbs Palsy
Keywords: Brachial plexus birth injury
Neuromuscular electrical stimulation
Active motion
Electroneurography
Motor function
Lead sponsor: Badr University
Sponsor class: OTHER
Collaborators: name: Prince Sattam Bin Abdulaziz University
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective single-blind randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.

Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of degeneration and motor function reaction were assessed pre-and post-treatment using electromyography and Toronto active motion scale, respectively.

Detailed description: This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.

Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of reaction of degeneration and motor function were assessed pre-and post-treatment using electromyography and the Toronto active motion scale respectively.

Eligibility criteria: Inclusion Criteria:

* Infants with OBPI limited to nerve roots C5, C6, with/without involvement of C7, partial lesion as determined by electrophysiological examinations, age between two to five months, and willingness of the infant's family to take part in the study.

Exclusion Criteria:

* Infants with clavicular or humeral fractures, complete transection of nerve roots, other neurological co-morbidities such cerebral palsy, congenital musculoskeletal deformities, or recommendation against electrical stimulation by the attending neuro-pediatrician.

Primary outcomes:
measure: Percentage of degeneration
timeFrame: 2 months
measure: Toronto active motion scale (TAMS)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al-Kharj
country: Saudi Arabia
facility: Prince Sattam bin Abdul-Aziz University
Study officials:
References: