Phantom Exercise for Lower Limb Amputees

NCT04285138 | Completed

• 1 other identifier: REC/Lhr/20/2008 Anna Zaheer
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In this research, the aim is to find out the effects of phantom exercises in terms of pain, mobility and quality of life among lower-limb amputees having phantom limb pain. This is a randomized control trial in which amputees having phantom limb pain will be randomly divided into two groups i.e. Experimental group (Routine physical therapy, mirror therapy and phantom exercises) and control group (Routine physical therapy and mirror therapy). Non-probability purposive sampling technique will be employed. Patients of age between 18 to 50 years and having phantom limb pain after lower limb amputation will be recruited by evaluating with limb deficiency and phantom limb questionnaire. Other tools will be Visual analogue scale (pain), Amputee mobility predictor (Ambulatory status) and 36-Item Short-Form Health Survey questionnaire (Health-related quality of life). The study will be conducted in 6 months and data obtained will be analyzed through Statistical Package for Social Sciences (SPSS) 20.

Conditions

Lower Limb Amputation

Keywords

Phantom; Amputation; Prosthesis

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale (VAS)

  changes from the baseline, The visual analogue scale The VAS evaluates pain subjectively. It consists of a 100-mm line, with two endpoints representing "no pain" to "worst pain imaginable from left to right." Patients are instructed to mark on the line according to the level of pain and the same is measured

  4 weeks

• Amputee Mobility predictor

  changes from the baseline, Amputee mobility predictor (AMP) is an amputee-specific tool for predicting ambulatory potential. This clinical test evaluates the predicted mobility of amputee with and without a prosthesis The AMP is a clinical test consisting of 20 tasks that are given a score of 0, 1, or 2 based on the amputee's performance. There is an item 21 where a score is given ranging from 0 to 5.

  4 weeks

• Limb Deficiency and Phantom Limb Questionnaire

  Patients will be evaluated using "Limb Deficiency and Phantom Limb Questionnaire (Questionnaire 2008, Version 2)" in order to assess their eligibility for including in this study. this questionnaire does not have any scoring, it only concludes the questions on Yes/No basis for presence or absence of phantom limb pain.

  day 1

Secondary Outcomes (1)

• Short form 36 (SF-36)

  4 weeks

Study Arms (2)

Phantom limb exercises

EXPERIMENTAL

Participants in this group will be treated with routine physical therapy, mirror therapy and Phantom limb exercises. Treatment time: 1 hour

Other: phantom limb exercise

conventional treatment

ACTIVE COMPARATOR

In this group, participants will be treated by routine physical therapy and mirror therapy protocol. Treatment time: 35 minutes

Other: conventional treatment

Interventions

phantom limb exercise OTHER

phantom limb exercises (that is, active imaginal efforts to move the phantom), under the assumption that the neural pathways involved in performing actual movements are activated when using one's imagination to move the phantom extremity

Phantom limb exercises

conventional treatment OTHER

Mirror therapy uses a flat mirror placed parasagittally in front of the patient's body with the reflective surface toward the sound limb so that the amputee sees the reflection of the sound limb in the mirror \[Figure 1\]. This reflection mimics the amputated limb, and with the movement of the intact limb, the mirror provides an optical illusion that the phantom limb is moving simultaneously. Equipment: Therapy mirror: A standing mirror (130 cm × 46 cm) with wooden frame and base (62 cm × 65 cm) Routine physiotherapy The general exercise programme consisted of strengthening, stretching, dynamic, and isometric exercises based on the level of amputation and their assessment results. Participants allocated to the control group were advised to continue rehabilitation at their respective physiotherapy out-patient departments as frequently as possible. Participants were given a diary and advised to record their activities, specifying the nature, frequency and duration of each activity

conventional treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unilateral lower limb amputation
• Phantom limb pain score (40-100 on VAS)
• Either gender
• Stable prosthetic situation (i.e. satisfaction with the fitting of the prosthesis) or being a non-user.

You may not qualify if:

• Amputees with psychological/neurological impairments.
• Amputees having neuropathic pain other than phantom limb pain.
• Patients having visual-spatial impairments.
• Taking pain relief medications will also be excluded.
• Patients having residual limb pain.
• Inability to give informed consent.
• Carcinoma
• Infectious stump
• Severe hearing loss
• Any condition that restricts the movement of opposite limb, pain or limited range of motion in the intact limb
• Infectious and systematic diseases

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (27)

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• Zaheer A, Malik AN, Masood T, Fatima S. Effects of phantom exercises on pain, mobility, and quality of life among lower limb amputees; a randomized controlled trial. BMC Neurol. 2021 Oct 27;21(1):416. doi: 10.1186/s12883-021-02441-z.

  PMID: 34706654 DERIVED

Study Officials

• Arshad Nawaz Malik, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phantom exercises involved imagining moving the phantom limb and then attempting to perform these movements The phantom exercises will be administered as follows: (i) subjects will be asked in which position they felt the phantom limb; (ii) they will be asked to place the intact limb in the same position as they felt their phantom limb; (iii) they will be asked to move both limbs in the opposite direction; (iv) they will be then asked to return to the starting position again.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: July 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)