NCT05460026

Brief Summary

The purpose for doing this study is to determine that whether use of Power Ball in form of resistance training will be effective in increasing grip strength in carpel tunnel syndrome patient and possible benefits of the regime as effective means of rehabilitation for wrist and hand injuries. Moreover for increasing grip strength it can be used as an adjunct for physical therapy treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

December 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

July 1, 2022

Last Update Submit

April 5, 2023

Conditions

Keywords

Physical therapyMedian NeuropathyPower Ball ExerciseCarpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity

    Pain Intensity will be measured by Numeric Rating Scale (NRS)

    Change in pain will be measured at initial visit, at sixth session and at the twelfth session.

  • Grip Strength

    Grip Strength will be measured by using handheld dynamometry (HHD)

    Change in grip strength will be measured at initial visit, at sixth session and at the twelfth session.

  • Functional Disability

    Functional disability will be measured by Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)

    Change in functional disability will be measured at initial visit, at sixth session and at the twelfth session.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Routine physical therapy will be given to the participants of group A

Other: Routine Physical Therapy

Group B

EXPERIMENTAL

Powerball exercises with routine physical therapy will be given to the participants of group B

Other: Powerball Exercises

Interventions

Participants will receive routine physical therapy which includes ultrasound, nerve gliding, tendon mobilization, stretching, mobility and strengthening exercises for the wrist. Each session will last for 30 minutes with 12 sessions on alternate days (3 sessions / week).

Group A

Participants will be using the Powerballâ„¢ for 5 minutes per hand, 3 times a week along with routine physical therapy exercises.

Group B

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 45-60 years
  • Both male and female
  • Clinically diagnosed carpal tunnel syndrome
  • Carpal Tunnel Syndrome for a duration of more than 02 months
  • Tingling sensation and numbness over the dorsal surface of thumb, index, middle, and lateral 1/3rd of ring fingers
  • Positive Tinel's sign
  • Positive Phalen's Maneuver

You may not qualify if:

  • Any previous trauma, fracture, subluxation, dislocation, surgery or bony abnormalities around wrist joint in the past 5 years.
  • Symptomatic Arthritis of wrist joint
  • Cervical radiculopathy
  • Corticosteroid injection within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Ashfaq Ahmed, PhD

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study will be single blinded in which the assessor will be unaware of the treatment intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 15, 2022

Study Start

December 23, 2021

Primary Completion

May 23, 2022

Study Completion

December 23, 2022

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Immediately after publication

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending on 36th month

Locations