Dry Needling Effects Post-traumatic Brain Injury

NCT05460728 | Completed DMC

• 1 other identifier: SREC/22/05/041
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty-six years old male with a history of TBI with compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait has participated in the study. Berg balance scale, 6-minute walk test, modified Ashworth scale, and functional independence measure was used to assess balance, gait, spasticity, and functional intemperance, respectively.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• modified Ashworth Scale (MAS)

  Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS) (Ghotbi, 2009). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb (Bohannon, 1987). The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90) (Mehrholz, 2005).

  Change from baseline MAS at 12-week and 16-week

Secondary Outcomes (3)

• 6-Minute Walk Teat (6-MWT)

  Change from baseline 6-MWT at 12-week and 16-week

• Berg Balance Scale (BBS)

  Change from baseline BBS at 12-week and 16-week

• Functional Independence Measure (FIM)

  Change from baseline FIM at 12-week and 16-week

Study Arms (1)

Dry needling

EXPERIMENTAL

Other: Dry needling

Interventions

Dry needling OTHER

A three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior (Hong, 1994). Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle.

Dry needling

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Traumatic brain injury

You may not qualify if:

• Unstable status

Sponsors & Collaborators

• Anas Radi Hassan Alashram: lead

Study Sites (1)

Isra University

Amman, 11199, Jordan

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• ANAS RADI H Annino

  University of Rome Tor Vergata

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: April 5, 2022
• Primary Completion: July 8, 2022
• Study Completion: July 9, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)